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Data / Medical devices / United States / Advanced Instrumentations, Inc.

Advanced Instrumentations, Inc.: FDA-registered device maker in Miami, FL, United States, 18 510(k) clearances

Advanced Instrumentations, Inc. is registered with the FDA (registration 1066270) in Miami, FL, United States. It lists 45 device types. The FDA files 18 510(k) clearances under its listings, the newest dated December 8, 2017. Registered through 2027. FDA data exported November 2, 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.

Get makers like this oneWatch Advanced Instrumentations, Inc.
FDA registration number
1066270
FEI number
3000957797
Address
6800 NW 77TH Court, Miami, FL, United States, 33166
Owner or operator
ADVANCED INSTRUMENTATIONS, INC. (9044980)
Roles
Manufacturer, Manufacturer for export, Specification developer
First device listed
February 13, 2012
Registered through
2027
Brand names listed
007-P Baby Basinett, A3150 Neonatal CPAP, AM-6000 Anesthesia Machine, AM-6000+ Anesthesia Machine, AM-6000XL Anesthesia Machine, B-1000 Crib Neonatal Crib, B-1000 E Electric Care Bed, B-1000 M Manual Care Bed and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Assisted ReproductionMQG2Specification developeraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Manufactureraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Manufactureraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Manufactureraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Manufactureraccessdata.fda.gov
Bassinet, HospitalNZG2Manufactureraccessdata.fda.gov
Bed, Ac-Powered Adjustable HospitalFNL2Manufactureraccessdata.fda.gov
Bed, ManualFNJ1Manufactureraccessdata.fda.gov
Blanket, Neonatal PhototherapyPDH2Manufacturer for exportaccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Manufactureraccessdata.fda.gov
Catheter, Intrauterine And IntroducerHGS2Manufactureraccessdata.fda.gov
Chair And Table, MedicalKMN1Manufactureraccessdata.fda.gov
Computer, Blood-PressureDSK2Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Manufactureraccessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)LDD2Specification developeraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Manufactureraccessdata.fda.gov
ElectrocardiographDPS2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Electrode, Circular (Spiral), Scalp And ApplicatorHGP2Manufactureraccessdata.fda.gov
Gas-Machine, AnesthesiaBSZ2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Incubator, NeonatalFMZ2Manufacturer for export, Specification developeraccessdata.fda.gov
Incubator, Neonatal TransportFPL2Manufacturer for exportaccessdata.fda.gov
Light, Surgical, Ceiling MountedFSY2Manufactureraccessdata.fda.gov
Light, Surgical, Floor StandingFSS2Manufactureraccessdata.fda.gov
Monitor, Blood-Flow, UltrasonicHEP2Manufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Manufactureraccessdata.fda.gov
Monitor, Ultrasonic, FetalKNG2Manufactureraccessdata.fda.gov
OximeterDQA2Manufactureraccessdata.fda.gov
Pump, InfusionFRN2Manufacturer for exportaccessdata.fda.gov
Recorder, Paper ChartDSF1Manufactureraccessdata.fda.gov
Stretcher, Hand-CarriedFPP1Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufactureraccessdata.fda.gov
System, Monitoring, PerinatalHGM2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Table, Operating-Room, ElectricalGDC1Manufactureraccessdata.fda.gov
Table, Operating-Room, Non-ElectricalFWY1Manufactureraccessdata.fda.gov
Transducer, Pressure, IntrauterineHFN2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufacturer, Specification developeraccessdata.fda.gov
Unit, Neonatal PhototherapyLBI2Manufacturer for export, Specification developeraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Manufacturer for exportaccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Specification developeraccessdata.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
December 8, 2017K172966CMS-2000 Central Monitoring SystemMHXSubstantially EquivalentAdvanced Instumentations, Inc.accessdata.fda.gov
December 1, 2017K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemIYOSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
August 31, 2017K172055DUS-7000 Digital Color Doppler Ultrasound SystemIYNSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
November 19, 2014K141194FM-3000 FETAL MONITORHGMSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
April 23, 2014K132077PATIENT MONITORMHXSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
February 18, 2014K131898A SERIES AND Q SERIES PATIENT MONITORSMWISubstantially EquivalentGuangdong Biolight Meditech Co., Ltd.accessdata.fda.gov
October 25, 2013K132059DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
January 11, 2013K123048PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PROMHXSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
May 25, 2012K120631PATIENT MONITORMHXSubstantially EquivalentAdvanced Instruments, Inc.accessdata.fda.gov
January 26, 2012K120075AM-6000 ANESTHESIA MACHINEBSZSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
December 21, 2011K112317FM-9000 PLUS FETAL AND MATERNAL MONITORHGMSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
October 27, 2011K112529TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLERKNGSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
September 22, 2011K112022DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYOSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
September 22, 2011K111934PD-100 SERIES ULTRASONIC POCKET DOPPLERKNGSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
September 21, 2011K112159CMS-1000FM CENTRAL MONITORING SYSTEMHGMSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
September 14, 2011K112465VITAL SIGNS MONITORDQASubstantially EquivalentAdvanced Instruments, Inc.accessdata.fda.gov
August 24, 2011K111805ECG SERIES ELECTROCARDIOGRAPHDPSSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov
August 5, 2011K112135ECG-6 SERIES ELECTROCARDIOGRAPHDPSSubstantially EquivalentAdvanced Instrumentations, Inc.accessdata.fda.gov

Compare with other makers

Updated December 8, 2017. 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.