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
- K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula2Cleared 510(K)
- K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)2Cleared 510(K)
- K233707HFT1502Cleared 510(K)
- K233821F&P Optiflow Oxygen Kit (AA451J)2Cleared 510(K)
- K222292F&P myAirvo 32Cleared 510(K)
- K231956F&P Optiflow+ Duet Nasal Cannula2Cleared 510(K)
- K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)2Cleared 510(K)
- K223863BONHAWA Respiratory Humidifier2Cleared 510(K)
- K223684F&P 820 Humidification System2Cleared 510(K)
- K231380AirLife DuoTherm™ Humidification System2Cleared 510(K)
- K223551Sterile Water for Inhalation in 1L Flexoval ® bottles.2Cleared 510(K)
- K220703F&P 950 Respiratory Humidifier2Cleared 510(K)
- K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range2Cleared 510(K)
- K222351inspired™ VHB20 Heated Humidifier2Cleared 510(K)
- K212031F&P 850 AirSpiral Adult NIV and NHF Circuit Kit2Cleared 510(K)
- K211096Optiflow Oxygen Kit2Cleared 510(K)
- K203357HVT 2.02Cleared 510(K)
- K201723F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling2Cleared 510(K)
- K193411O2asis Personal Oxygen Humidifier2Cleared 510(K)
- K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)2Cleared 510(K)
- K191010Palladium High Flow Therapy System2Cleared 510(K)
- K162553AirSpiral Heated Breathing Tube2Cleared 510(K)
- K180474TNI softFlow 502Cleared 510(K)
- K161719Salter Labs Bubble Humidifier2Cleared 510(K)
- K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC40102Cleared 510(K)
- K162242Comfort Flo Humidification System2Cleared 510(K)
- K160764AirLife Autofill Humidification Chamber2Cleared 510(K)
- K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE2Cleared 510(K)
- K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC40102Cleared 510(K)
- K143646MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit2Cleared 510(K)
- K141940CONCHASMART COLUMN2Cleared 510(K)
- K133766HUMICARE D9002Cleared 510(K)
- K140556CONCHASMART BREATHING CIRCUIT2Cleared 510(K)
- K141353HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR2Cleared 510(K)
- K132857RESPIRATORY GAS HUMIDIFIER2Cleared 510(K)
- K132017HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT2Cleared 510(K)
- K131912CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN2Cleared 510(K)
- K131957MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT2Cleared 510(K)
- K131895AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER2Cleared 510(K)
- K131388TRANSCEND HEATED HUMIDIFIER2Cleared 510(K)
- K122885MEDISIZE GOLD HEATER AND BOOSTER T-PIECE2Cleared 510(K)
- K122705HUMICARE D9002Cleared 510(K)
- K121975AIRVO HUMIDIFIER MYAIRO HUMIDIFIER2Cleared 510(K)
- K110019RESPIRATORY HUMIDIFER2Cleared 510(K)
- K113542SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)2Cleared 510(K)
- K111640PRECISION FLOW(R) - HELIOX2Cleared 510(K)
- K103316FLOWREST2Cleared 510(K)
- K093617VENTLAB 6000 SERIES HUMIDIFIER2Cleared 510(K)
- K102618VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED2Cleared 510(K)
- K092256THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC700122Cleared 510(K)
- K100554RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR4412Cleared 510(K)
- K092846AIRVO SERIES HUMIDIFIERS2Cleared 510(K)
- K090915STERILE WATER FOR INHALATION FLEX BAG, USP2Cleared 510(K)
- K080149HEATER BASE, MODEL PMH70002Cleared 510(K)
- K072845PRECISION FLOW2Cleared 510(K)
- K080797HUMIDAIRE 2I2Cleared 510(K)
- K073706RESPIRATORY HUMIDIFIER, MODEL MR8502Cleared 510(K)
- K072982PARI HYDRATE V2Cleared 510(K)
- K071958THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS2Cleared 510(K)
- K070714MEDISIZE GOLD HEATER AND BOOSTER2Cleared 510(K)
- K063758CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R2Cleared 510(K)
- K070056VAPOTHERM MODEL# 2000I AND 2000H2Cleared 510(K)
- K070107PARI HYDRATE G2Cleared 510(K)
- K062664HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-0042Cleared 510(K)
- K061736COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA2Cleared 510(K)
- K062091POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION2Cleared 510(K)
- K060790BREAS, MODEL HA012Cleared 510(K)
- K052615MEDISIZE GOLD2Cleared 510(K)
- K050990REMREST HEATED HUMIDIFIER2Cleared 510(K)
- K050314AQUINOX2Cleared 510(K)
- K042184GOODKNIGHT H20, MODEL M-114600-002Cleared 510(K)
- K041963AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI2Cleared 510(K)
- K042245VAPOTHERM MODEL#2000I, 200H2Cleared 510(K)
- K020700PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY2Cleared 510(K)
- K033710MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU2Cleared 510(K)
- K031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP40002Cleared 510(K)
- K040507TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H2Cleared 510(K)
- K031179TAGA VELOCITY HUMIDIFIER2Cleared 510(K)
- K031383MODEL 7802Cleared 510(K)
- K020332RESPIRATORY HUMIDIFIER, MODEL MR8502Cleared 510(K)
- K013486VAPOTHERM 2000H2Cleared 510(K)
- K013856PMH 1000 HEATED HUMIDIFIER2Cleared 510(K)
- K030090H2 HEATED HUMIDIFIER2Cleared 510(K)
- K020900DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM2Cleared 510(K)
- K012633RESPIRONICS HEATED HUMIDIFIER2Cleared 510(K)
- K003973RESPIRATORY HUMIDIFIER, MODEL HC1502Cleared 510(K)
- K003626DEVILBISS HUMIDIFIER2Cleared 510(K)
- K010578TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP10172Cleared 510(K)
- K003561INVACARE PASSOVER HUMIDIFIER MODEL ISP97002Cleared 510(K)
- K010402SMOOTH-FLO CIRCUIT2Cleared 510(K)
- K002454BREAS HA50 HUMIDIFIER, MODEL HA502Cleared 510(K)
- K001213CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -602Cleared 510(K)
- K983783HEATED HUMIDIFIER2Cleared 510(K)
- K993282IPI HUMIDIFIER CHAMBER2Cleared 510(K)
- K993773HUMID-HEAT2Cleared 510(K)
- K000401VAPOTHERM, MODEL 2000I2Cleared 510(K)
- K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-432Cleared 510(K)
- K990614HME-BOOSTER2Cleared 510(K)
- K993268MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT2Cleared 510(K)
- K983862CLOUD 1 HUMIDIFICATION SYSTEM2Cleared 510(K)
- K991484AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 0020062Cleared 510(K)
- K983112RESPIRATORY HUMIDIFIER, MODEL # MR8502Cleared 510(K)
- K971260SULLIVAN HUMIDAIRE HEATED HUMIDIFIER2Cleared 510(K)
- K970478SCT 3000 HEATED HUMIDIFIER2Cleared 510(K)
- K964653OASIS HUMIDIFIER2Cleared 510(K)
- K962223WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER2Cleared 510(K)
- K963025SLEEPNET HUMIDIFIER,(84200 PACKAGED)2Cleared 510(K)
- K962079HUMIDIFIER ADAPTER2Cleared 510(K)
- K953392HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)2Cleared 510(K)
- K945782HUMIDIFIER2Cleared 510(K)
- K950582SULLIVAN PASSOVER HUMIDIFER2Cleared 510(K)
- K923946CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER2Cleared 510(K)
- K936000PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION2Cleared 510(K)
- K934140MR290 HUMIDIFICATION CHAMBER SINGLE USE2Cleared 510(K)
- K926161RES Q AIR SYSTEM MODEL HT-10002Cleared 510(K)
- K932570MARK I HUMIDIFIER2Cleared 510(K)
- K915460HEATED RESPIRATORY HUMIDIFIER HC1002Cleared 510(K)
- K923754MISTY OX LAMINAR DIFFUSER HUMIDIFIER2Cleared 510(K)
- K913367MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS2Cleared 510(K)
- K915890AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED2Cleared 510(K)
- K914686THERMO-FLOW SET2Cleared 510(K)
- K920306OPTI-MOL FILTERED PUNCTURE PIN2Cleared 510(K)
- K913368MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC2Cleared 510(K)
- K911770OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM2Cleared 510(K)
- K903138MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM2Cleared 510(K)
- K902970PRECISION MEDICAL DISPOSABLE HUMIDIFIER2Cleared 510(K)
- K901762PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM2Cleared 510(K)
- K900854JOHN BUNN: MEDIX COMPACT TRAVELLER2Cleared 510(K)
- K900602DEVILBISS AP-50 COMPRESSOR/NEBULIZER2Cleared 510(K)
- K900569THERMOPROBE 2102Cleared 510(K)
- K896315BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY2Cleared 510(K)
- K892817HEATED RESPIRATORY HUMIDIFIER2Cleared 510(K)
- K893122HEATED SERVO HUMIDIFIER, MODEL HDS 22Cleared 510(K)
- K894000THERA-MIST HUMIDIFIER2Cleared 510(K)
- K893034VHS 820 HUMIDIFIER, MODIFICATION2Cleared 510(K)
- K881970MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER2Cleared 510(K)
- K885314HPD STERILE HUMIDIFYING CHAMBER2Cleared 510(K)
- K884150MODIFIED CONCHATHERM III CONTROLLED HEATER2Cleared 510(K)
- K882582STERILE INHALATION WATER TRANSFER SET2Cleared 510(K)
- K880979MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM2Cleared 510(K)
- K880702MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES2Cleared 510(K)
- K881184INTERTECH STERILE WATER FOR INHALATION2Cleared 510(K)
- K874659STERILIZATION OF DEVICES BY RADIATION2Cleared 510(K)
- K873472MEMBRANE HUMIDIFIER2Cleared 510(K)
- K873634BEAR VH-820 HUMIDIFIER2Cleared 510(K)
- K872138MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER2Cleared 510(K)
- K872139MR420 TRANSPORT HUMIDIFIER2Cleared 510(K)
- K871618PREFILLED STERILE WATER FOR INHALATION, USP2Cleared 510(K)
- K870173LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL2Cleared 510(K)
- K863377MR338 SERVO HEATED DELIVERY HUMIDIFIER2Cleared 510(K)
- K870055MR590 DUAL HOSE HEATER POWER PACK2Cleared 510(K)
- K864173HPD HUMIDIFYING CHAMBER2Cleared 510(K)
- K863154HEATED JET HUMIDIFIER MODEL AMS-10202Cleared 510(K)
- K863955COLBY LEVEL ALARM2Cleared 510(K)
- K862923MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER2Cleared 510(K)
- K854363SARATOGA SCT HEATED HUMIDIFICATION SYSTEM2Cleared 510(K)
- K851879HEATED RESPIRATORY HUMIDIFIER2Cleared 510(K)
- K853146RESPIR THER HUMID CONTAIN STERILE WATER FOR USP2Cleared 510(K)
- K851940STERILE WATER FOR INHALATION USP 2D07992Cleared 510(K)
- K850647HEATED RESPIRATORY HUMIFIFIER MR4402Cleared 510(K)
- K843903HEATED RESPIRATORY HUMIDIFIER MR4282Cleared 510(K)
- K843932VAPOR-PHASE HUMIDIFIER SYS-ADVANCED2Cleared 510(K)
- K842795MAXI-MISER HUMIDIFIER INSERT 10302Cleared 510(K)
- K842794MAXI-MISER HUMIDIFIER INSERT 1020 & 10212Cleared 510(K)
- K841295HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS2Cleared 510(K)
- K842340VH820 HUMIDIFIER2Cleared 510(K)
- K842523BIRD HEATED HUMIDIFIER 32012Cleared 510(K)
- K841851HPD HUMIDIFIER WICK2Cleared 510(K)
- K841158NEBULO 28 NEBULIZER KIT2Cleared 510(K)
- K834151CONCHATHERM LHF HUMIDIFIER HEATER2Cleared 510(K)
- K833974AQUAPAK 020 HUMIDIFIER ADAPTER2Cleared 510(K)
- K832928SERVO HEATED RESPIRATORY HUMIDIFIER2Cleared 510(K)
- K831556VAPOR-PHASE HUMIDIFIER SYSTEM2Cleared 510(K)
- K830913MINITROP AEROSAL, PRODOMO AEROSAL AND2Cleared 510(K)
- K831163LO-COMP RESERVOIR-RE-10002Cleared 510(K)
- K823143BUBBLE HUMIDIFIERS2Cleared 510(K)
- K822816DUAL SERVO HEATED RESPIRATORY HUMIDIFIER2Cleared 510(K)
- K820878CONCHO PEDIATRIC PACK2Cleared 510(K)
- K812957EAST AUTOCLAVE HUMIDIFIER2Cleared 510(K)
- K811073A QUAPAK2Cleared 510(K)
- K810939NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.2Cleared 510(K)
- K810559OPTI- SYSTEM2Cleared 510(K)
- K810219PREFILLED HUMIDIFER2Cleared 510(K)
- K802852HUMIDIFIER2Cleared 510(K)
- K8021452C 7140 HEATED HUMIDIFER CANNISTER2Cleared 510(K)
- K8021442M8101 HEATED LIQUID LEVEL CONTROLLER2Cleared 510(K)
- K801619MIST2GEN TEMPTROL 102Cleared 510(K)
- K801252NEBULIZER WITH AIR ENTERTAINER & ETC.2Cleared 510(K)
- K800753STERILE WATER & SALINE IN PLASTIC BTL.2Cleared 510(K)
- K792620NEONATAL HEATED HUMIDIFIER2Cleared 510(K)
- K800056VENTILATOR SET2Cleared 510(K)
- K791683STERILE WATER FOR RESPIRATORY THERAPY2Cleared 510(K)
- K790731OXYGEN HUMIDIFIER KIT2Cleared 510(K)
- K781760HUMIDIFIERS, MODEL:LS-420 AND LS-4602Cleared 510(K)
- K781600MISTY-OX PREFILLED HUMIDIFIER, DISP.2Cleared 510(K)
- K781537NEBULIZER/HUMIDIFIER2Cleared 510(K)
- K781468CONTINUOUS FEED VALVE 2D90242Cleared 510(K)
- K780845CONCHANEOPAK A CARTRIDGE HUMIDIFIER2Cleared 510(K)
- K780385RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE2Cleared 510(K)
- K780381RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE2Cleared 510(K)
- K780562AQUAPAK PREFILLED HUMIDIFIER2Cleared 510(K)
- K780088HYMIDIFIER2Cleared 510(K)
- K770415HUMIDIFIER, DISPOSABLE2Cleared 510(K)
- K770249VENTILATOR SET - CODE 2C71092Cleared 510(K)
- K761293RESPIRATORY HUMIDIFIER2Cleared 510(K)
- K760923HUMIDIFIER-CASCADE II2Cleared 510(K)
- K760938DISPOSABLE HUMIDIFIER2Cleared 510(K)
- K760866CONCHA-COLUMN2Cleared 510(K)
- K760584U-MID PREFILLED HUMIDIFIER (500CC)2Cleared 510(K)
- K760587U-MID PREFILLED HUMIDIFIER (300CC)2Cleared 510(K)
- K760566PREFILLED HUMIDIFIER2Cleared 510(K)
- K760372HUMIDIFIER, DISPOSABLE2Cleared 510(K)
- K760037HEATER, IMMERSION W/ HUMIDIFIER & NEBUL.2Cleared 510(K)
- 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
- 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
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K031176
- 510(k) Type
- Traditional
- Applicant
- INVACARE CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/25/2004
- Days to Decision
- 346 days
- Submission Type
- Summary