Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- 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
- BRWProtector, Dental1Product Code
- BSFAbsorber, Carbon-Dioxide1Product Code
- BSJMask, Gas, Anesthetic1Product Code
- BSKCuff, Tracheal Tube, Inflatable2Product Code
- BSNFilter, Conduction, Anesthetic2Product Code
- BSOCatheter, Conduction, Anesthetic2Product Code
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2Product Code
- BSRStylet, Tracheal Tube1Product Code
- BSZGas-Machine, Anesthesia2Product Code
- BTBHook, Ether1Product Code
- BTCBag, Reservoir1Product Code
- BTKStrap, Head, Gas Mask1Product Code
- BTLVentilator, Emergency, Powered (Resuscitator)2Product Code
- BTMVentilator, Emergency, Manual (Resuscitator)2Product Code
- BTOTube, Tracheostomy (W/Wo Connector)2Product Code
- BTPDropper, Ether1Product Code
- BTQAirway, Nasopharyngeal1Product Code
- BTRTube, Tracheal (W/Wo Connector)2Product Code
- BTSTube, Bronchial (W/Wo Connector)2Product Code
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2Product Code
- BWBForceps, Tube Introduction1Product Code
- BWCNeedle, Emergency Airway2Product Code
- BWFSpirometer, Therapeutic (Incentive)2Product Code
- BWLApparatus, Electronanesthesia3Product Code
- BYDCondenser, Heat And Moisture (Artificial Nose)1Product Code
- BYEAttachment, Breathing, Positive End Expiratory Pressure2Product Code
- BYFMask, Oxygen, Low Concentration, Venturi1Product Code
- BYGMask, Oxygen1Product Code
- BYHDrain, Tee (Water Trap)1Product Code
- BYIPercussor, Powered-Electric2Product Code
- BYJUnit, Liquid-Oxygen, Portable2Product Code
- BYKTent, Oxygen, Electrically Powered2Product Code
- BYLTent, Oxygen1Product Code
- BYNChair, Posture, For Cardiac And Pulmonary Treatment1Product Code
- BYOBottle, Blow1Product Code
- BYPMouthpiece, Breathing1Product Code
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)2Product Code
- BYWDevice, Rebreathing1Product Code
- BYXTubing, Pressure And Accessories1Product Code
- BZAConnector, Airway (Extension)1Product Code
- BZBCatheter, Nasal, Oxygen1Product Code
- BZDVentilator, Non-Continuous (Respirator)2Product Code
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2Product Code
- BZOSet, Tubing And Support, Ventilator (W Harness)1Product Code
- BZRMixer, Breathing Gases, Anesthesia Inhalation2Product Code
- CADVaporizer, Anesthesia, Non-Heated2Product Code
- CAEAirway, Oropharyngeal, Anesthesiology1Product Code
- CAFNebulizer (Direct Patient Interface)2Product Code
- CAGCirculator, Breathing-Circuit2Product Code
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)1Product Code
- K954480CONDENSATE COLLECTION KIT1Cleared 510(K)
- K953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORS1Cleared 510(K)
- K952018PRIMA COAXIAL CIRCUITS1Cleared 510(K)
- K952017PRIMA MAPLESON D CIRCUIT1Cleared 510(K)
- K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITS1Cleared 510(K)
- K952014PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1Cleared 510(K)
- K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITS1Cleared 510(K)
- K952019PRIMA ADULT GAS SAMPLING CIRCUITS1Cleared 510(K)
- K952009PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS1Cleared 510(K)
- K945565SPIRO-FLEX1Cleared 510(K)
- K932288NEONATAL BREATHING CIRCUIT MODIFICATION1Cleared 510(K)
- K945984MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS1Cleared 510(K)
- K944533PRIMA, INC. ADULT ANESTHESIA CIRCUIT1Cleared 510(K)
- K945314CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING1Cleared 510(K)
- K944429PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING1Cleared 510(K)
- K940889CONNECTORS AND AIRWAY EXTENSIONS1Cleared 510(K)
- K940890CORRUGATED TUBING1Cleared 510(K)
- K944295KARL STORZ LARYNGOSCOPE ACCESSORIES1Cleared 510(K)
- K942136M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS1Cleared 510(K)
- K942135M.A.G. INC. COAXIAL CIRCUITS1Cleared 510(K)
- K942133M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS1Cleared 510(K)
- K942132M.A.G. INC. HYPERINFLATION SYSTEM1Cleared 510(K)
- K942131M.A.G. INC. GUEDEL AIRWAYS1Cleared 510(K)
- K942130M.A.G. INC. MAPLESON D CIRCUITS1Cleared 510(K)
- K942129M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1Cleared 510(K)
- K942128M.A.G. INC. ADULT GAS SAMPLING CIRCUITS1Cleared 510(K)
- K942122PEDIATRIC ANESTHESIA CIRCUITS1Cleared 510(K)
- K942134M.A.G. INC. BREALTHING BAGS1Cleared 510(K)
- K942127M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS1Cleared 510(K)
- K942126M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K942125VOLUME VENTILATOR1Cleared 510(K)
- K942124GAS SAMPLING LINES AND CONNECTORS CIRCUITS1Cleared 510(K)
- K942123M.A.G. INC. VENTILATOR HOSES1Cleared 510(K)
- K942570MAPLESON D CIRCUIT1Cleared 510(K)
- K942568ADULT ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K934462ADULT ANESTHESIA BREATHING CIRCUIT KITS1Cleared 510(K)
- K935168ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS1Cleared 510(K)
- K932780MALE/MALE LUER TRANSFER TUBING1Cleared 510(K)
- K932781DUAL VALVED RESPIRATORY T1Cleared 510(K)
- K931487BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE1Cleared 510(K)
- K935044EASYFLOW AIRWAY ADAPTER1Cleared 510(K)
- K933641BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE1Cleared 510(K)
- K930713THE INFANT FLOW SYSTEM1Cleared 510(K)
- K932708PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS1Cleared 510(K)
- K932707ADULT ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K932710GAS SAMPLING LINES AND CONNECTORS1Cleared 510(K)
- K932562GAS SAMPLING LINES AND CONNECTORS1Cleared 510(K)
- K932577PEDIATRIC GAS SAMPLING1Cleared 510(K)
- K932590ADULT GAS SAMPLING CIRCUITS1Cleared 510(K)
- K932589PEDIATRIC GAS SAMPLING CIRCUITS1Cleared 510(K)
- K932558ADULT ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K932575ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1Cleared 510(K)
- K932576PEDIATRIC TEMPERATURE MONITORING CIRCUITS1Cleared 510(K)
- K932578ADULT GAS SAMPLING CIRCUITS1Cleared 510(K)
- K932489PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR.1Cleared 510(K)
- K932497PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING1Cleared 510(K)
- K932488PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS1Cleared 510(K)
- K932583ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1Cleared 510(K)
- K932588PEDIATRIC TEMPERATURE MONITORING CIRCUITS1Cleared 510(K)
- K932486PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT1Cleared 510(K)
- K932582CUSTOM ANESTHESIA CIRCUITS1Cleared 510(K)
- K932559MAPLESON D CIRCUITS1Cleared 510(K)
- K932585PEDIATRIC ANESTHESIA CIRCUITS1Cleared 510(K)
- K932586CUSTOM ANESTHESIA CIRCUITS1Cleared 510(K)
- K932587COAXIAL CIRCUITS1Cleared 510(K)
- K932579COAXIAL CIRCUITS1Cleared 510(K)
- K932580PEDIATRIC ANESTHESIA CIRCUITS1Cleared 510(K)
- K932490PMP, LTD. CUSTOM ANESTHESIA CIRCUITS1Cleared 510(K)
- K932485PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITS1Cleared 510(K)
- K932487PMP, LTD. PEDIATRIC ANESTHESIA CIRCUITS1Cleared 510(K)
- K932196COAXIAL CIRCUITS1Cleared 510(K)
- K932195ADULT GAS SAMPLING CIRCUITS1Cleared 510(K)
- K932194PEDIATRIC GASSAMPLING CIRCUITS1Cleared 510(K)
- K932193PEDIATRIC TEMPERATURE MONITORING CIRCUITS1Cleared 510(K)
- K932192PEDIATRIC ANESTHESIA CIRCUITS1Cleared 510(K)
- K932190ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1Cleared 510(K)
- K932197CUSTOM ANESTHESIA CIRCUITS1Cleared 510(K)
- K926454ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON1Cleared 510(K)
- K922789KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT1Cleared 510(K)
- K925543BLD-18000 SERIES HEATED BREATHING CIRCUIT1Cleared 510(K)
- K924627XTEND CIRCUITS (TM)1Cleared 510(K)
- K924889ZEFON ADULT ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K925893OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K930252BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)1Cleared 510(K)
- K925231MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS1Cleared 510(K)
- K925232MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT1Cleared 510(K)
- K915452ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K911880ZEFON ADULT ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K913753BODAI NEO2 -SAFE AIRWAY PRESSURE CAP1Cleared 510(K)
- K912504DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED1Cleared 510(K)
- K912065DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED1Cleared 510(K)
- K91126322MM ID/OD ADAPTER1Cleared 510(K)
- K911736MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT1Cleared 510(K)
- K905450ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE1Cleared 510(K)
- K910896DISPOSABLE ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K904538MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT1Cleared 510(K)
- K905148TEMPERATURE PROBE1Cleared 510(K)
- K901739THAYER METERED DOSE INHALER DISPENSER/ADAPTER1Cleared 510(K)
- K900428ANESTHESIA BREATHING CIRCUITS1Cleared 510(K)
- K900594ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K896897VENTLAB ANESTHESIA CIRCUIT AC 60001Cleared 510(K)
- K896365BABYFLEX HEATED INFANT BREATHING CIRCUIT1Cleared 510(K)
- K895357ANETHESIA BREATHING CIRCUIT1Cleared 510(K)
- K893919ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP1Cleared 510(K)
- K890499BIVONA VENTILATOR ISOLATOR SYSTEM1Cleared 510(K)
- K891479DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITS1Cleared 510(K)
- K88407215 MILLIMETER MALE AND FEMALE ADAPTERS1Cleared 510(K)
- K881141PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K880683KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE1Cleared 510(K)
- K870859BAG-TAIL BLEED VALVE1Cleared 510(K)
- K871386BREATHING CIRCUIT1Cleared 510(K)
- K871669BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE1Cleared 510(K)
- K864588PENLON CIRCLE SYSTEM1Cleared 510(K)
- K862003CIRCUIT ANES. BREATHING & COMPONENTS1Cleared 510(K)
- K861438CIRCUIT, ANES. BREATHING (NON-REBREATHING)1Cleared 510(K)
- K854573ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE1Cleared 510(K)
- K852632GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB1Cleared 510(K)
- K852866HYDRO-BAC FILTER1Cleared 510(K)
- K852405LASERSAFE PERSONNEL AND PATIENT SHIELDS1Cleared 510(K)
- K853065#6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAG1Cleared 510(K)
- K8533444000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT1Cleared 510(K)
- K8533433015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W1Cleared 510(K)
- K8533426013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG1Cleared 510(K)
- K852314#6010 NON-CONDUCTIVE VENTILATOR CIRCUIT1Cleared 510(K)
- K852312#3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG1Cleared 510(K)
- K852316#3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG1Cleared 510(K)
- K852315#3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG1Cleared 510(K)
- K852313#3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG1Cleared 510(K)
- K852311#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG1Cleared 510(K)
- K851193ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K8515314013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAG1Cleared 510(K)
- K8515304003 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREAT\GAS1Cleared 510(K)
- K8515294010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL1Cleared 510(K)
- K844149AMBU RUBEN CIRCLE ANESTHESIA SYSTEM1Cleared 510(K)
- K842492AMER. MEDICAL PLASTICS CO 201001Cleared 510(K)
- K842488SAMSON 1000 ANESTHESIA CIRCUIT1Cleared 510(K)
- K841264BABYSET TM & PAC TM -PULMONARY ASSIST1Cleared 510(K)
- K841455REUSEABLE NON-CONDUCTIVE FIXED Y1Cleared 510(K)
- K840431SCRATCH & SNIFF FOR ANESTHESIA1Cleared 510(K)
- K840740CIRCUIT BREATHING1Cleared 510(K)
- K840850ANESTHESIA VENTILATOR CIRCUIT1Cleared 510(K)
- K840056PEDIATRIC INTUBATION CIRCUIT1Cleared 510(K)
- K833871UNIVERSAL CONTROL ARM1Cleared 510(K)
- K833478HUMPHREY A.D.E. SYSTEM1Cleared 510(K)
- K833196VOLUME VENTILATOR CIRCUIT-NEBULIZER1Cleared 510(K)
- K833088SPIROMETER ISOLATION VALVE #88901Cleared 510(K)
- K832453SLIMB SINGLE LIMB BREATHING CIRCUIT1Cleared 510(K)
- K830475BRAIN MODULE RJ-Z101Cleared 510(K)
- K830470ANESTHESIA BREATHING CIRCUITS1Cleared 510(K)
- K823714DISPOSABLE NON-REBREATHING ANES. CIRCUIT1Cleared 510(K)
- K822769THORATEC GAS SAMPLING CONNECTOR1Cleared 510(K)
- K822379DISPOSABLE ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K821311ESPREE' BREATHING CIRCUIT (W/ACCESS1Cleared 510(K)
- K821087ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K821086M T M CIRCUIT1Cleared 510(K)
- K820352ANALGESIA BREATHING CIRCUIT1Cleared 510(K)
- K813382DISPOSABLE ADULT ANES. CIRCUIT1Cleared 510(K)
- K812624OXEQUIP CONDUCTIVE & NON ANES. BREATH1Cleared 510(K)
- K811858KHI CPRAM BREATHING CIRCUIT1Cleared 510(K)
- K811700CIRCUIT, BREATHING1Cleared 510(K)
- K811413DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR1Cleared 510(K)
- K811015POSITIVE CLOSURE ANESTHETIC VALVE1Cleared 510(K)
- K801191ANESTHESIA BREATHING CIRCUITS1Cleared 510(K)
- K801111PEDIATRIC ANESTHESIA CIRCUIT1Cleared 510(K)
- K800498ADULT ANESTHESIA BREATHING CIRCUITS . .1Cleared 510(K)
- K800499PEDIATRIC ANESTHESIA BREATHING CIRCUITS1Cleared 510(K)
- K792499AMBU PAEDI ANAESTHESIA SYSTEM1Cleared 510(K)
- K790214MODIFIED JACKSON-REES CIRCUIT1Cleared 510(K)
- K790115BREATHING CIRCUIT, DISPOSABLE1Cleared 510(K)
- K781908BREATHING CIRCUIT PRODUCTS, ANESTHESIA1Cleared 510(K)
- K780044BREATHING CIRCUIT, BAIN1Cleared 510(K)
- K771518INSPIRATORY FORCE ADAPTOR1Cleared 510(K)
- K771307BAIN BREATHING CIRCUIT1Cleared 510(K)
- K771034HI-MID CURCUIT1Cleared 510(K)
- K771134ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K771017CITADEL CPAP ACCESSORY KIT1Cleared 510(K)
- K770838ANESTHESIA BREATHING CIRCUIT, DISPOSABLE1Cleared 510(K)
- K770549PEDIATRIC ANESTHESIA CIRCUIT1Cleared 510(K)
- K770286VENTILATOR BREATHING CIRCUIT1Cleared 510(K)
- K760819CONDUCTIVE ANESTHESIA BREATHING CIRCUIT1Cleared 510(K)
- K760565VENTILATOR CIRCUITS1Cleared 510(K)
- K760149CONDUCTIVE ANESTHSIA BREATH. CIRCUIT1Cleared 510(K)
- CALLaryngoscope, Non-Rigid1Product Code
- CAOAirway, Esophageal (Obturator)2Product Code
- CATCannula, Nasal, Oxygen1Product Code
- CAWGenerator, Oxygen, Portable2Product Code
- CAZAnesthesia Conduction Kit2Product Code
- CBFChamber, Hyperbaric2Product Code
- CBGSpreader, Cuff1Product Code
- CBHDevice, Fixation, Tracheal Tube1Product Code
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2Product Code
- CBKVentilator, Continuous, Facility Use2Product Code
- CBLAbsorbent, Carbon-Dioxide1Product Code
- CBNApparatus, Gas-Scavenging2Product Code
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)2Product Code
- CBPValve, Non-Rebreathing2Product Code
- MODAccessory To Continuous Ventilator (Respirator)2Product Code
- CCOBed, Rocking, Breathing Assist2Product Code
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1Product Code
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia2Product Code
- CCWLaryngoscope, Rigid1Product Code
- EPEBrush, Cleaning, Tracheal Tube1Product Code
- FNCTent, Pediatric Aerosol2Product Code
- FOGHood, Oxygen, Infant1Product Code
- JAYSupport, Breathing Tube1Product Code
- JOHTube Tracheostomy And Tube Cuff2Product Code
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)1Product Code
- KGBMask, Oxygen, Non-Rebreathing1Product Code
- KHAMask, Scavenging1Product Code
- LNZChanger, Tube, Endotracheal2Product Code
- MIANeedle, Spinal, Short Term2Product Code
- MNSVentilator, Continuous, Non-Life-Supporting2Product Code
- MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use2Product Code
- MRNApparatus, Nitric Oxide Delivery2Product Code
- MROApparatus, Nitric Oxide, Backup Delivery2Product Code
- MZTDevice, Heimlich Maneuver Assist2Product Code
- NFBConserver, Oxygen2Product Code
- NHJDevice, Positive Pressure Breathing, Intermittent2Product Code
- NHKResuscitator, Manual, Non Self-Inflating2Product Code
- NMATube, Tracheal, Reprocessed2Product Code
- NMCMask, Ventilator, Non-Continuous, Reprocessed2Product Code
- NMRNeedle, Spinal, Short Term, Reprocessed2Product Code
- NNHNeedle, Conduction, Anesthesia, Reprocessed2Product Code
- NOUContinuous, Ventilator, Home Use2Product Code
- NQYVentilator, Continuous, Minimal Ventilatory Support, Home Use2Product Code
- NVOSpacer, Direct Patient Interface2Product Code
- NVPHolding Chambers, Direct Patient Interface2Product Code
- NXATracheotomy Care Kit2Product Code
- OBNHumidifier, Respiratory, Mask (Direct Patient Interface)2Product Code
- OFQAnesthesia Kit2Product Code
- OFTSpinal Epidural Anesthesia Kit2Product Code
- OFUSpinal Anesthesia Kit2Product Code
- OFVRegional Anesthesia Kit2Product Code
- OGABrachial Plexus Anesthesia Kit2Product Code
- OGBCaudal Anesthesia Kit2Product Code
- OGCContinuous Brachial Plexus Block Tray2Product Code
- OGDCustom Anesthesia Tray2Product Code
- OGEEpidural Anesthesia Kit2Product Code
- OGFGlossopharyngeal Anesthesia Kit2Product Code
- OGGHumidifier Nebulizer Kit2Product Code
- OGHLaryngoscope Kit1Product Code
- OGINasal Endotracheal Tube Holder Kit1Product Code
- OGJNerve Block Tray2Product Code
- OGLOxygen Administration Kit2Product Code
- OLFMedevac Use Oxygen Generator2Product Code
- ONZMechanical Ventilator2Product Code
- OQUAirway Monitoring System2Product Code
- PHSOral Airway Assist1Product Code
- PMBExternal Airway2Product Code
- QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device2Product Code
- QBYPositive Airway Pressure System2Product Code
- QCXRetrograde Intubation Set2Product Code
- OZRIntraoral Pressure Gradient Device2Product Code
- QFBIsocapnic Ventilation Device2Product Code
- 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
BIVONA VENTILATOR ISOLATOR SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K890499
- 510(k) Type
- Traditional
- Applicant
- BIVONA MEDICAL TECHNOLOGIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/15/1989
- Days to Decision
- 134 days