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Data / Medical devices / Mexico / Plexus Electronica S. de R.L. de C.V..

Plexus Electronica S. de R.L. de C.V..: FDA-registered device maker in Zapopan Jalisco, Mexico, 27 510(k) clearances

Plexus Electronica S. de R.L. de C.V.. is registered with the FDA (registration 3011120183) in Zapopan Jalisco, Mexico. It lists 36 device types. The FDA files 27 510(k) clearances under its listings, the newest dated July 10, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3011120183
Address
Paseo del Norte #4640 Guadalajara Technology Park, Zapopan Jalisco, Mexico, 45010
Owner or operator
PLEXUS CORP. (3019588)
Roles
Contract manufacturer, Exporter to the US
First device listed
November 14, 2007
Registered through
2026
Brand names listed
A6, BS System, LDx, N.A.-RECERT, A6,BS System, LDx, N.A.-RENTAL, ALICE PDX, AV300, AV400, AV500, AccuVein HF510 Hands-free stand, AccuVein HF550 Hands-free stand and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Exporter to the USaccessdata.fda.gov
Automatic Event Detection Software For Polysomnograph With ElectroencephalographOLZ2Exporter to the USaccessdata.fda.gov
Catheter, Coronary, AtherectomyMCX3Contract manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE3Contract manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD3Contract manufactureraccessdata.fda.gov
Collector, Urine, Powered, Non Indwelling CatheterNZU1Contract manufactureraccessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use VentilatorMNT2Exporter to the USaccessdata.fda.gov
Continuous, Ventilator, Home UseNOU2Exporter to the USaccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Contract manufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Contract manufactureraccessdata.fda.gov
Device, Positive Pressure Breathing, IntermittentNHJ2Exporter to the USaccessdata.fda.gov
Device, Vein Location, Liquid CrystalKZA1Contract manufactureraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Generator, Oxygen, PortableCAW2Exporter to the USaccessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE2Exporter to the USaccessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT2Exporter to the USaccessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)LWS3Contract manufactureraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUContract manufactureraccessdata.fda.gov
Integrated Continuous Glucose Monitoring System, Factory CalibratedQBJ2Contract manufactureraccessdata.fda.gov
Intra-Pulmonary Percussive Vibration (Ipv) DevicesSDT2Exporter to the USaccessdata.fda.gov
Laryngoscope, RigidCCW1Contract manufactureraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Contract manufactureraccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Contract manufactureraccessdata.fda.gov
Percussor, Powered-ElectricBYI2Exporter to the USaccessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI3Contract manufactureraccessdata.fda.gov
Permanent Defibrillator ElectrodesNVY3Contract manufactureraccessdata.fda.gov
Programmer, PacemakerKRG3Contract manufactureraccessdata.fda.gov
Pulse Generator, Permanent, ImplantableNVZ3Contract manufactureraccessdata.fda.gov
Separator, Automated, Blood Cell, DiagnosticGKT2Contract manufactureraccessdata.fda.gov
Standard Polysomnograph With ElectroencephalographOLV2Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract manufactureraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Exporter to the USaccessdata.fda.gov
Ventilator, Continuous, Non-Life-SupportingMNS2Exporter to the USaccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Exporter to the USaccessdata.fda.gov
Ventilatory Effort RecorderMNR2Exporter to the USaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 10, 2020K200480DreamStation 2 System, DreamStation 2 Advanced SystemBZDSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
July 18, 2019K181166Trilogy EvoCBKSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
October 18, 2013K131982REMSTAR AUTO A-FLEX HTBZDSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
December 31, 2012K122111RESPIRONICS SIMPLYCLEAR DEVICESDTSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
December 14, 2012K121955COUGHASSIST T70 DEVICENHJSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
December 14, 2012K121623BIPAP A 40 VENTILATORY SUPPORT SYSTEMMNTSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
October 9, 2012K122769REMSTAR SEBZDSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
February 1, 2012K113053BIPAP A 30 VENTILATORY SUPPORT SYSTEMMNSSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
December 16, 2011K113068REMSTAR AUTO A-FLEX HTBZDSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
November 4, 2011K111885SIMPLYGO PORTABLE OXYGEN CONCENTRATORCAWSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
March 24, 2011K102465BIPAP AVAPS VENTILATORY SUPPORT SYSTEMMNSSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
May 12, 2010K093905TRILOGY 202 VENTILATORCBKSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
January 29, 2010K093416TRILOGY 200 VENTILATORCBKSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
January 22, 2010K092818BIPAP AVAPS VENTILATORY SUPPORT SYSTEMMNSSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
October 30, 2009K090539BIPAP AUTOSV ADVANCEDMNSSubstantially EquivalentRespironics Inc., Sleep & Home Respiratory Groupaccessdata.fda.gov
August 3, 2009K091319REMSTAR AUTO A-FLEXBZDSubstantially EquivalentRespironics Inc., Sleep & Home Respiratory Groupaccessdata.fda.gov
June 26, 2009K090484ALICE PDXMNRSubstantially EquivalentRespironics Inc., Sleep & Home Respiratory Groupaccessdata.fda.gov
May 8, 2009K090243REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEMBZDSubstantially EquivalentRespironics Inc., Sleep & Home Respiratory Groupaccessdata.fda.gov
March 13, 2009K083526TRILOGY 100 VENTILATORCBKSubstantially EquivalentRespironics Inc., Sleep & Home Respiratory Groupaccessdata.fda.gov
January 26, 2009K083874GALAXYMNRSubstantially EquivalentRespironics Inc., Sleep & Home Respiratory Groupaccessdata.fda.gov
June 28, 2006K061261L4 OXYGEN CONCENTRATORCAWSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
December 13, 2005K053063PRO-FLOW MULTIPURPOSE CANNULACCKSubstantially EquivalentPro-Tech Services, Inc.accessdata.fda.gov
June 17, 2005K051383THE INCOURAGE SYSTEMBYISubstantially EquivalentRespiratory Technologies, Incorporatedaccessdata.fda.gov
February 11, 2005K043006MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605CAWSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
March 18, 2004K040595ALICE 5OLZSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
June 19, 2002K021861REMSTAR PRO WITH C-FLEX CPAP SYSTEMBZDSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
March 29, 2001K010263REMSTAR PLUS CPAP SYSTEMBZDSubstantially EquivalentRespironics, Inc.accessdata.fda.gov

Compare with other makers

Updated July 10, 2020. 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.