Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- BXHGauge, Gas Pressure, Cylinder/Pipeline1Product Code
- BXMStimulator, Nerve, Ac-Powered2Product Code
- BXNStimulator, Nerve, Battery-Powered2Product Code
- BXOTransducer, Gas Pressure1Product Code
- BXPTransducer, Gas Flow1Product Code
- BXXCalibrator, Pressure, Gas1Product Code
- BXYFlowmeter, Calibration, Gas1Product Code
- BYMTube, Thorpe, Uncompensated1Product Code
- BYRTransducer, Gas Pressure, Differential1Product Code
- BZQMonitor, Breathing Frequency2Product Code
- CANRegulator, Pressure, Gas Cylinder1Product Code
- K162811MR Conditional CGA 8701Cleared 510(K)
- K080243PORTABLE OXYGEN UNIT SCA9001Cleared 510(K)
- K060265REMCORE REMOTE CONTROLLED OXYGEN REGULATOR1Cleared 510(K)
- K061785CYL-FIL OXYGEN SYSTEM1Cleared 510(K)
- K950777OXYGEN REGULATOR1Cleared 510(K)
- K942751VANGUARD SERIES GAS REGULATORS1Cleared 510(K)
- K936187LSPI PRESSURE REGULATOR1Cleared 510(K)
- K9320061500 SERIES REGULATOR1Cleared 510(K)
- K921125AMBU OXYGEN REGULATOR1Cleared 510(K)
- K915154GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS1Cleared 510(K)
- K915505REGULATOR FLOWMETER1Cleared 510(K)
- K914271GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)1Cleared 510(K)
- K912174SALTER LABS DISPOSABLE NIPPLE AND NUT1Cleared 510(K)
- K901831PRECISION MEDICAL OXYGEN REGULATOR1Cleared 510(K)
- K901623AMBU OXYGEN REGULATOR1Cleared 510(K)
- K895956RX02 EMERGENCY MEDICAL OXYGEN1Cleared 510(K)
- K900115VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B1Cleared 510(K)
- K896152PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.1Cleared 510(K)
- K896128PURITAN-BENNETT OXYGEN PRESSURE REGULATOR1Cleared 510(K)
- K8948508053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI1Cleared 510(K)
- K894302OXYGEN THERAPY REGULATOR1Cleared 510(K)
- K893621CONCOA PRESSURE REGULATORS1Cleared 510(K)
- K891771VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED1Cleared 510(K)
- K884927BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER1Cleared 510(K)
- K883483AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR1Cleared 510(K)
- K872170CRT PORTABLE EMERGENCY OXYGEN INHALATOR1Cleared 510(K)
- K865077ACCU-FLO REGULATOR1Cleared 510(K)
- K863711REGULATOR OXYGEN MECHANICAL1Cleared 510(K)
- K862796AIRCO PRESSURE REGULATORS1Cleared 510(K)
- K862193# 10099/10225/10235/10275/10525/10625/10715/101251Cleared 510(K)
- K853039PRESSURE REGULATOR1Cleared 510(K)
- K861166OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER1Cleared 510(K)
- K852333DOWNS VPAP CIRCUIT1Cleared 510(K)
- K852663PORTABLE GASEOUS OXGYEN CONTAINER1Cleared 510(K)
- K852649PRESSURE REGULATOR/Y CONNECTOR1Cleared 510(K)
- K852374OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT181Cleared 510(K)
- K844622SAV-A-LIFE1Cleared 510(K)
- K850106AIRCO NITROUS OXIDE REGULATOR1Cleared 510(K)
- K843585BEMCO PORTABLE OXYGEN INHALATOR1Cleared 510(K)
- K841367AIRCO OXYGEN REGULATOR1Cleared 510(K)
- K834061SLO-FLO 40AL ADJUST-FLOW REGULATOR1Cleared 510(K)
- K830844PORTABLE OXYGEN SYSTEM1Cleared 510(K)
- K8134664004 CONSTANT FLOW REGULATOR1Cleared 510(K)
- K8134672002 ADJUSTABLE FLOW REGULATOR1Cleared 510(K)
- K811430ANESTHESIOLOGY DEVICE1Cleared 510(K)
- K810679MS-303-OXYGEN REGULATOR SHIELD1Cleared 510(K)
- K810132MODEL 2 FLOWMETER1Cleared 510(K)
- K803207REGULATOR, OXYGEN MECHANICAL1Cleared 510(K)
- K802644EMERG. OXYGEN KIT #65350 & #65399 CASE1Cleared 510(K)
- K780750O2 CONNECTOR1Cleared 510(K)
- K780359OXYGEN REGULATOR/FLOWMETER1Cleared 510(K)
- K780364MANIFOLD KIT1Cleared 510(K)
- K780084OXYGEN THERAPY KIT1Cleared 510(K)
- K772216PORT-A-BOUT 2401Cleared 510(K)
- K771241SPIR-E-VAC1Cleared 510(K)
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)2Product Code
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated1Product Code
- CBAMonitor, Air Embolism, Ultrasonic2Product Code
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge1Product Code
- ECXCylinder, Compressed Gas, And Valve1Product Code
- FLSMonitor, Apnea, Facility Use2Product Code
- JAXPneumotachometer2Product Code
- JEZMonitor, Lung Water Measurement3Product Code
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia2Product Code
- KOIStimulator, Nerve, Peripheral, Electric2Product Code
- LKDMonitor, Carbon-Dioxide, Cutaneous2Product Code
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia2Product Code
- MNRVentilatory Effort Recorder2Product Code
- MRPAnalyzer, Nitric Oxide2Product Code
- MRQAnalyzer, Nitrogen Dioxide2Product Code
- NPFMonitor, Apnea, Home Use2Product Code
- PRKDevice Indicating An Exhalation Event2Product Code
- PUGAnalyzer, Nitrogen Dioxide, Exempt2Product Code
- PXEPressure Monitoring (Air/Gas) Kit1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AMBU OXYGEN REGULATOR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K901623
- 510(k) Type
- Traditional
- Applicant
- FLOTEC, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/26/1990
- Days to Decision
- 20 days