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Data / Medical devices / China / Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 120 510(k) clearances

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is registered with the FDA (registration 3009156722) in Shenzhen Guangdong, China. It lists 54 device types. The FDA files 120 510(k) clearances under its listings, the newest dated June 25, 2026. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3009156722
Address
1203 Nanhuan Avenue Guangming District, Shenzhen Guangdong, China, 518106
Owner or operator
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD (9058402)
Roles
Manufacturer, Specification developer
First device listed
February 17, 2008
Registered through
2026
Brand names listed
A3 ANESTHESIA DELIVERY SYSTEM, A4 Anesthesia System, A5 ANESTHESIA DELIVERY SYSTEM, A5 Anesthesia System, A7 Anesthesia System, A8, A9 Anesthesia System, ACCUTORR 7,VS-900 VITAL SIGNS MONITOR, ACUSON Bonsai Diagnostic Ultrasound System and more

Devices it lists

DeviceProduct codeClassRoleSource
Alarm, Blood-PressureDSJ2Manufactureraccessdata.fda.gov
Amplifier And Signal Conditioner, Transducer SignalDRQ2Manufactureraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Manufactureraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Manufactureraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Manufactureraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Manufactureraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Manufactureraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Manufactureraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Manufactureraccessdata.fda.gov
Burst Suppression Detection Software For ElectroencephalographORT2Manufactureraccessdata.fda.gov
Computer, Blood-PressureDSK2Manufacturer, Specification developeraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Manufacturer, Specification developeraccessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use VentilatorMNT2Manufactureraccessdata.fda.gov
Counter, Differential CellGKZ2Manufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Manufacturer, Specification developeraccessdata.fda.gov
DetergentJCB1Manufactureraccessdata.fda.gov
Diluent, Blood CellGIF1Manufactureraccessdata.fda.gov
Electrode, CutaneousGXY2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Manufactureraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Manufactureraccessdata.fda.gov
Gas-Machine, AnesthesiaBSZ2Manufactureraccessdata.fda.gov
Hexokinase, GlucoseCFR2Manufactureraccessdata.fda.gov
Index-Generating Electroencephalograph SoftwareOLW2Manufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Manufacturer, Specification developeraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Manufacturer, Specification developeraccessdata.fda.gov
Monitor, St SegmentMLC2Manufactureraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Manufacturer, Specification developeraccessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph SoftwareOLT2Manufactureraccessdata.fda.gov
OximeterDQA2Manufacturer, Specification developeraccessdata.fda.gov
Oximeter, EarDPZ2Manufactureraccessdata.fda.gov
Oximeter, Tissue SaturationMUD2Manufactureraccessdata.fda.gov
Plethysmograph, ImpedanceDSB2Manufactureraccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Manufactureraccessdata.fda.gov
Reduced- Montage Standard ElectroencephalographOMC2Manufactureraccessdata.fda.gov
Regulator, VacuumKDP2Manufactureraccessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)BZK2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Peripheral, ElectricKOI2Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufacturer, Specification developeraccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Manufactureraccessdata.fda.gov
Tester, Electrode, Surface, ElectrocardiographicKRC2Manufactureraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufactureraccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Manufactureraccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Manufactureraccessdata.fda.gov
Vaporizer, Anesthesia, Non-HeatedCAD2Manufactureraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 120.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 25, 2026K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 20, 2026K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)MHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 11, 2026K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);DiagnosIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 16, 2026K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 6, 2026K252182SV70 Ventilator (SV70)MNTSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
February 11, 2026K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
December 3, 2025K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
November 7, 2025K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 12, 2025K251820ViewMateTM Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 5, 2025K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)IYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
August 28, 2025K243767SV600, SV800 VentilatorCBKSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
August 22, 2025K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)IYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 31, 2025K242728BeneVision Central Monitoring SystemMSXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 30, 2025K250024TE Air Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 19, 2025K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); DiagnostIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 16, 2025K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);IYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
November 8, 2024K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 31, 2024K240375V80 Anesthetic Vaporizer (V80)CADSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 16, 2024K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 12, 2024K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 23, 2024K240906TE Air Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
June 17, 2024K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 22, 2024K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 26, 2023K231685TE Air Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
June 16, 2023K220107Mindray SV600 Ventilator, Mindray SV800 VentilatorCBKSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
June 9, 2023K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
February 7, 2023K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
December 15, 2022K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs MonitorMWISubstantially EquivalentShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.accessdata.fda.gov
December 2, 2022K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorMWISubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
November 9, 2022K222754ViewMate Multi Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.accessdata.fda.gov
September 29, 2022K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 29, 2022K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 12, 2022K213799N Series Patient MonitorsMHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 25, 2022K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 4, 2022K220051TE Air Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
November 16, 2021K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
November 5, 2021K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 5, 2021K211475Vital Signs MonitorsMWISubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 1, 2021K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
June 10, 2021K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
June 10, 2021K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 8, 2021K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.accessdata.fda.gov
March 26, 2021K201957A8, A9 Anesthesia SystemBSZSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 23, 2021K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
January 7, 2021K202405BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1MHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
November 9, 2020K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
August 21, 2020K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 24, 2020K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/FibrousIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
June 8, 2020K200015ePM Series Patient monitorsMHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 28, 2020K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 21, 2020K193391BeneVision Central Monitoring SystemMSXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 7, 2020K192972Patient MonitorMHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 9, 2020K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 8, 2020K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 2, 2020K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
December 19, 2019K192410ZS3 and z.one pro Ultrasound SystemsIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
December 13, 2019K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 31, 2019K191769ePM Series Patient monitorsMHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 10, 2019K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)MHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 9, 2019K183660DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 4, 2019K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 27, 2019K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorMWISubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 13, 2019K183238BeneVision Central Monitoring SystemMSXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 8, 2019K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
January 10, 2019K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
January 9, 2019K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
December 10, 2018K182075BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)MHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
November 14, 2018K182603Z6 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 24, 2018K180788Gas Module 3BZKSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 30, 2018K180912TE7/TE5 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
January 12, 2018K171311A5 Anesthesia SystemBSZSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
January 12, 2018K171292A7 Anesthesia SystemBSZSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
January 8, 2018K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
December 13, 2017K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.accessdata.fda.gov
November 15, 2017K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)MHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 25, 2017K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 18, 2017K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 21, 2017K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 12, 2017K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.accessdata.fda.gov
August 23, 2017K170876Passport Series Patient Monitors(Passport 12m, Passport 17m)MHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
August 2, 2017K170712Accutorr 7/VS-900 Vital Signs MonitorMWISubstantially EquivalentShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.accessdata.fda.gov
July 10, 2017K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 20, 2017K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
April 20, 2017K162607BeneVision Central Monitoring SystemMSXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 23, 2017K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
December 15, 2016K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 6, 2016K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 1, 2016K160429BC-5390 Auto Hematology AnalyzerGKZSubstantially EquivalentMindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 13, 2016K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
June 9, 2016K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerJGSSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 3, 2016K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)MHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
February 18, 2016K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)MHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 29, 2015K152543M9/M9CV/M9T Diagnostic Ultrasound SystemIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
October 27, 2015K151954A7 Anesthesia SystemBSZSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
September 2, 2015K150082Panorama Patient Monitoring NetworkMHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
August 21, 2015K143348BC-3600 Auto Hematology AnalyzerGKZSubstantially EquivalentMindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
June 30, 2015K150167V60 Anesthetic VaporizerCADSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 15, 2015K151175ZONARE ZS3 Diagnostic Ultrasound SystemIYNSubstantially EquivalentZonare Medical Systems, Inc.accessdata.fda.gov
April 10, 2015K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsIYNSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
March 4, 2015K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemIYNSubstantially EquivalentZonare Medical Systems, Inc.accessdata.fda.gov

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Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.