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
- 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
- K241135RESPOND(R) Ventilator2Cleared 510(K)
- K241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask2Cleared 510(K)
- K232836Family of DIMAR DMAX NIV masks2Cleared 510(K)
- K240807VM-20002Cleared 510(K)
- K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask2Cleared 510(K)
- K232365Vivo 45 LS2Cleared 510(K)
- K231778Nihon Kohden NKV-550 Series Ventilator System2Cleared 510(K)
- K213098Panther 52Cleared 510(K)
- K220107Mindray SV600 Ventilator, Mindray SV800 Ventilator2Cleared 510(K)
- K222644Nihon Kohden NKV-440 Ventilator System2Cleared 510(K)
- K222207Babylog VN800, Babylog VN6002Cleared 510(K)
- K222024Evita V800, Evita V6002Cleared 510(K)
- K201082LTV2 Series Ventilators2Cleared 510(K)
- K210384CARESCAPE R8602Cleared 510(K)
- K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.12Cleared 510(K)
- K203449F&P Visairo NIV Mask Range2Cleared 510(K)
- K201306HAMILTON-C32Cleared 510(K)
- K202970Ventway Sparrow2Cleared 510(K)
- K201658Hamilton-C62Cleared 510(K)
- K193056Puritan Bennett 980 Series Ventilator System2Cleared 510(K)
- K192604Servo-air 4.0 Ventilator System2Cleared 510(K)
- K193228Hamilton-G52Cleared 510(K)
- K192307Nihon Kohden NKV-550 Series Ventilator System2Cleared 510(K)
- K183364Bellavista2Cleared 510(K)
- K181216HAMILTON-T1, HAMILTON-C12Cleared 510(K)
- K180295Hamilton-G52Cleared 510(K)
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented2Cleared 510(K)
- K181170Trilogy Evo Universal2Cleared 510(K)
- K181166Trilogy Evo2Cleared 510(K)
- K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.12Cleared 510(K)
- K180779Savina 3002Cleared 510(K)
- K181695Nihon Kohden NKV-550 Series Ventilator System2Cleared 510(K)
- K173973TV-1002Cleared 510(K)
- K172875Astral 100/1502Cleared 510(K)
- K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version2Cleared 510(K)
- K162738Puritan Bennett 980 Ventilator System2Cleared 510(K)
- K170037Breathe Technologies Life2000™ Ventilation System2Cleared 510(K)
- K162832731 Series Ventilators2Cleared 510(K)
- K163127bellavista 10002Cleared 510(K)
- K161450HAMILTON-C32Cleared 510(K)
- K162877VOCSN Unified Respiratory System2Cleared 510(K)
- K153046HAMILTON-MR12Cleared 510(K)
- K152068Astral 100/1502Cleared 510(K)
- K143035Flight 60 Ventilator2Cleared 510(K)
- K151252Puritan Bennett 840 Series Ventilator System2Cleared 510(K)
- K151814SERVO-U Ventilator System, SERVO-n Ventilator System2Cleared 510(K)
- K151901AirView2Cleared 510(K)
- K150638AF541 SE Full Face Mask2Cleared 510(K)
- K140939HAMILTON-T1,HAMILTON-C12Cleared 510(K)
- K142679CARESCAPE R8602Cleared 510(K)
- K141943BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM2Cleared 510(K)
- K140575ENGSTROM CARESTATION, ENGSTROM PRO2Cleared 510(K)
- K121886SAVINA 300 SAVINA 300, COUNTRY VARIANTS2Cleared 510(K)
- K123149SERVO-I VENTILATOR SYSTEM2Cleared 510(K)
- K133868ASTRAL VENTILATOR2Cleared 510(K)
- K130171FLIGHT 60 VENTILATOR2Cleared 510(K)
- K131252PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM2Cleared 510(K)
- K122438HAMILTON-MR12Cleared 510(K)
- K130178INSPIRATION VENTILATOR SYSTEM 5I/7I2Cleared 510(K)
- K131774HAMILTON-G52Cleared 510(K)
- K120931CRITICAL CARE VENTILATOR2Cleared 510(K)
- K122560VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V12Cleared 510(K)
- K123637HAMILTON-C32Cleared 510(K)
- K113743EVOLUTION 3E VENTILATOR2Cleared 510(K)
- K120146QUARK SERIES2Cleared 510(K)
- K121225HAMILTON-C22Cleared 510(K)
- K121891NEWPORT AURA VENTILATOR2Cleared 510(K)
- K121379PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY2Cleared 510(K)
- K120639PERFORMAX PEDIATRIC SE TOTAL FACE MASK2Cleared 510(K)
- K120726FLIGHT 60 VENTILATOR2Cleared 510(K)
- K112754IVENT1012Cleared 510(K)
- K112729BLEASE700/900 SERIES VENTILATORS2Cleared 510(K)
- K120574HAMILTON-C12Cleared 510(K)
- K120670HAMILTON-T12Cleared 510(K)
- K113051SPACELABS ARKON ANESTHESIA WORKSTATION2Cleared 510(K)
- K111473UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR2Cleared 510(K)
- K112006HAMILTON-TC12Cleared 510(K)
- K111595NEUMOVENT GRAPHNET2Cleared 510(K)
- K110083V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE2Cleared 510(K)
- K111146NEWPORT HT70 VENTILATOR2Cleared 510(K)
- K103803HAMILTON-G52Cleared 510(K)
- K111683FLIGHT 60 VENTILATOR2Cleared 510(K)
- K111610TRILOGY SERIES VENTILATOR WITH OXIMETRY2Cleared 510(K)
- K103625OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE2Cleared 510(K)
- K111116ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-0002Cleared 510(K)
- K110795V200 INTELLI-TRAK OPTION2Cleared 510(K)
- K102120NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 102022Cleared 510(K)
- K103211AVEA VENTILATOR2Cleared 510(K)
- K103318UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR2Cleared 510(K)
- K101850SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION2Cleared 510(K)
- K101643MODEL LTV 1100 VENTILATOR2Cleared 510(K)
- K102775HAMILTON-C22Cleared 510(K)
- K102054V200 VENTILATOR2Cleared 510(K)
- K101401NEUMOVENT GRAPHNET MODEL 3179L1V2Cleared 510(K)
- K101129ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK2Cleared 510(K)
- K101803NEWPORT E360 VENTILATOR2Cleared 510(K)
- K100753FLIGHT 60 VENTILATOR, MODEL F-602Cleared 510(K)
- K093905TRILOGY 202 VENTILATOR2Cleared 510(K)
- K093094VELA VENTILATOR2Cleared 510(K)
- K093886ENGSTROM CARESTATION, ENGSTROM PRO2Cleared 510(K)
- K093632INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE2Cleared 510(K)
- K093633INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE2Cleared 510(K)
- K092847840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION2Cleared 510(K)
- K092148HAMILTON-C22Cleared 510(K)
- K093416TRILOGY 200 VENTILATOR2Cleared 510(K)
- K092263ENDURAVENT-5 VENTILATOR2Cleared 510(K)
- K092648RESPIRONICS PERFORMAX SE TOTAL FACE MASK2Cleared 510(K)
- K092264ATLANTIS HYPERBARIC CHAMBER VENTILATOR2Cleared 510(K)
- K092135MODIFICATION TO IVENT 1012Cleared 510(K)
- K090888NEWPORT HT70 FAMILY OF VENTILATORS2Cleared 510(K)
- K091238UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+2Cleared 510(K)
- K090468HAMILTON-C22Cleared 510(K)
- K083693PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 8402Cleared 510(K)
- K083688PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR2Cleared 510(K)
- K081845IVENT1012Cleared 510(K)
- K083526TRILOGY 100 VENTILATOR2Cleared 510(K)
- K083122HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT0412Cleared 510(K)
- K082351NEPTUNE HYPERBARIC VENTILATOR2Cleared 510(K)
- K083050EVITE XL2Cleared 510(K)
- K082724NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM2Cleared 510(K)
- K071526UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV2Cleared 510(K)
- K082600OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)2Cleared 510(K)
- K082966PB 540 VENTILATOR2Cleared 510(K)
- K072926HELONTIX VENT2Cleared 510(K)
- K081670THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK2Cleared 510(K)
- K081842ENGSTROM CARESTATION, ENGSTROM PRO2Cleared 510(K)
- K081521MODIFICATION TO HAMILTON-G52Cleared 510(K)
- K081743CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS2Cleared 510(K)
- K081837AVEA VENTILATOR2Cleared 510(K)
- K080181MODIFICATION TO GALILEO GOLD2Cleared 510(K)
- K073179SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 66755852Cleared 510(K)
- K073694IVENT 2001 MRI CONDITIONAL2Cleared 510(K)
- K072885CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 57041102Cleared 510(K)
- K072412OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 68715002Cleared 510(K)
- K073069MODIFICATION TO AVEA VENTILATOR2Cleared 510(K)
- K072590INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM2Cleared 510(K)
- K072588PERFORMAX SE TOTAL FACE MASK2Cleared 510(K)
- K070899PURITAN BENNETT LEGENDAIR XL22Cleared 510(K)
- K072450ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V10002Cleared 510(K)
- K070513HAMILTON-G52Cleared 510(K)
- K071194RAPHAEL COLOR ASV VENTILATOR2Cleared 510(K)
- K070594PALMTOP VENTILATOR, MODELS PTV-8, PTV-102Cleared 510(K)
- K071212ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V10002Cleared 510(K)
- K063806SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED2Cleared 510(K)
- K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 8402Cleared 510(K)
- K063404SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 8002Cleared 510(K)
- K062793SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION2Cleared 510(K)
- K062710GE DATEX-OHMEDA ENGSTROM CARESTATION2Cleared 510(K)
- K062267OXYLOG 30002Cleared 510(K)
- K062093AVEA VENTILATOR2Cleared 510(K)
- K062019RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD2Cleared 510(K)
- K061094NEWPORT E500 WAVE VENTILATOR2Cleared 510(K)
- K061090GALILEO GOLD ASV2Cleared 510(K)
- K061627MODIFICATION TO I VENT 2012Cleared 510(K)
- K060705CARINA HOME2Cleared 510(K)
- K060862GE DATEX-OHMEDA ENGSTROM CARESTATION2Cleared 510(K)
- K060647LTV 1200 VENTILATOR2Cleared 510(K)
- K060549AUTOMOBILE LIGHTER POWER CORD2Cleared 510(K)
- K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION2Cleared 510(K)
- K053270IVENT 2012Cleared 510(K)
- K053502NEWPORT E360 VENTILATOR2Cleared 510(K)
- K052863RAPHAEL COLOR2Cleared 510(K)
- K051895GE DATEX-OHMEDA ENGSTROM CARESTATION2Cleared 510(K)
- K052554MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR2Cleared 510(K)
- K051222AV-S ANAESTHESIA VENTILATOR2Cleared 510(K)
- K051767LTV 1000 VENTILATOR2Cleared 510(K)
- K051550INSPIRATION VENTILATOR SYSTEM2Cleared 510(K)
- K051263EVITAXL WITH OPTION SMARTCARE2Cleared 510(K)
- K051262ESPRIT VENTILATOR NEONATAL OPTION, MODEL V10002Cleared 510(K)
- K050860GE DATEX-OHMEDA CENTIVA/5 VENTILATOR2Cleared 510(K)
- K050597GE DATEX-OHMEDA ENGSTROM CARESTATION2Cleared 510(K)
- K043085MODIFICATION TO: PNEUTON VENTILATOR2Cleared 510(K)
- K042468IVENT 201 PORTABLE VENTILATOR2Cleared 510(K)
- K040574GALILEO GOLD2Cleared 510(K)
- K041775GE DATEX-OHMEDA ENGSTROM CARESTATION2Cleared 510(K)
- K032922CLARISSA INFANT NCPAP CANNULA2Cleared 510(K)
- K041524GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM2Cleared 510(K)
- K041223MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E2Cleared 510(K)
- K041412ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V10002Cleared 510(K)
- K040790MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS2Cleared 510(K)
- K040642LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA2Cleared 510(K)
- K040540MODIFICATION TO LTV 1000 VENTILATOR2Cleared 510(K)
- K032451BIRD TBIRD VELA VENTILATOR2Cleared 510(K)
- K040221SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E2Cleared 510(K)
- K030780NEWPORT E500 WAVE VENTILATOR2Cleared 510(K)
- K034040ESPRIT VENTILATOR, MODEL V10002Cleared 510(K)
- K030341MODIFICATION TO INSPIRATION VENTILATOR SYSTEM2Cleared 510(K)
- K022679RAPHAEL2Cleared 510(K)
- K032226LTV-1000 VENTILATOR2Cleared 510(K)
- K023366DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS2Cleared 510(K)
- K024344PNEUTON VENTILATOR2Cleared 510(K)
- K030515HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS2Cleared 510(K)
- K023289OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 84140722Cleared 510(K)
- K023135IMAGE3 SE DISPOSABLE FULL FACE MASK2Cleared 510(K)
- K012691MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES2Cleared 510(K)
- K021112INSPIRATION VENTILATOR SYSTEM2Cleared 510(K)
- K023350ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS2Cleared 510(K)
- K022674BIRD AVEA VENTILATOR2Cleared 510(K)
- K022132SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E2Cleared 510(K)
- K021573PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION2Cleared 510(K)
- K012693MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES2Cleared 510(K)
- K013642AVEA2Cleared 510(K)
- K020746BIRD TBIRD VELA VENTILATOR2Cleared 510(K)
- K010793OXYLOG 1000, MODEL 2M868402Cleared 510(K)
- K010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E2Cleared 510(K)
- K012177VENTVIEW, MODEL 84140952Cleared 510(K)
- K010317AV 800 VENTILATOR2Cleared 510(K)
- K011957IVENT 201 PORTABLE VENTILATOR2Cleared 510(K)
- K003068SAVINA2Cleared 510(K)
- K010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 4742Cleared 510(K)
- K010608MODIFICATION TO LAP TOP VENTILATOR (LTV)2Cleared 510(K)
- K003770BIRD TBIRD LEGACY VENTILATOR2Cleared 510(K)
- K002951MAGELLAN VENTILATOR2Cleared 510(K)
- K001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION2Cleared 510(K)
- K002686ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E2Cleared 510(K)
- K002881VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 10002Cleared 510(K)
- K992133NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL2Cleared 510(K)
- K001686GALILEO VENTILATOR2Cleared 510(K)
- K001208ESPIRT2Cleared 510(K)
- K993449BIRD V.I.P. GOLD/STERLING2Cleared 510(K)
- K993071PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 8402Cleared 510(K)
- K990177NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR2Cleared 510(K)
- K993167MILLENNIUM INFANT VENTILATOR2Cleared 510(K)
- K972833E100M VENTILATOR (E100M)2Cleared 510(K)
- K992670OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 0672Cleared 510(K)
- K992788BEAR CUB 750 PSV2Cleared 510(K)
- K982910HAMILTON MEDICAL GALILEOVENTILATOR2Cleared 510(K)
- K992608ATC OPTION FOR EVITA 2 DURA AND EVITA 42Cleared 510(K)
- K982132BLEASE 6200 ANAESTHESIA VENTILATOR2Cleared 510(K)
- K984056LTV 10002Cleared 510(K)
- K981668SMARTVENT 201 PORTABLE VENTILATOR2Cleared 510(K)
- K990429MODIFICATION OF VENTURI VENTILATOR2Cleared 510(K)
- K984577DRAGER OXYLOG 20002Cleared 510(K)
- K984535PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION2Cleared 510(K)
- K984379NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM2Cleared 510(K)
- K983219NEOFLOW OPTION MODEL NUMBERS 8413563, 84119002Cleared 510(K)
- K981412M1145 (UPS1-1.25K-1G-MP) UPS2Cleared 510(K)
- K983981BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE2Cleared 510(K)
- K981072ESPRIT VENTILATOR2Cleared 510(K)
- K981371LTV 1000 VENTILATOR2Cleared 510(K)
- K982580BIRD MONITOR INTERFACE2Cleared 510(K)
- K980642EVITA 4 (8411900)2Cleared 510(K)
- K981971TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 32Cleared 510(K)
- K980208DIVAN ANESTHESIA VENTILATOR2Cleared 510(K)
- K982174VENTURI VENTILATOR2Cleared 510(K)
- K974176BABYLOG 8000 PLUS2Cleared 510(K)
- K970460NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)2Cleared 510(K)
- K970158BABYPAC2Cleared 510(K)
- K964540NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM2Cleared 510(K)
- K972203BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT2Cleared 510(K)
- K970839SERVO VENTILATOR 300A2Cleared 510(K)
- K972248NELLCOR PURITAN BENNETT GEMINI2Cleared 510(K)
- K970165EVITA 2 DURA2Cleared 510(K)
- K964543INFRASONICS ADULT VENTILATOR TRENDING OPTION2Cleared 510(K)
- K961687EVITA 42Cleared 510(K)
- K950853OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS2Cleared 510(K)
- K960168SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 9902Cleared 510(K)
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- K953238DRAGER MICRO VENT2Cleared 510(K)
- K960861OMICRON MONITOR, DELTA MONITOR2Cleared 510(K)
- K955865BEAR CUB INFANT PRESSURE VENTILATOR2Cleared 510(K)
- K952880MODEL LP-1000 VOLUME VENTILATOR2Cleared 510(K)
- K950484TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR2Cleared 510(K)
- K953228NARKOMED AV2+ ANESTHESIA VENTILATOR2Cleared 510(K)
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- K863546CPU GRAPH2Cleared 510(K)
- K862712EMERSON MODEL 3HV COMPACT VENTILATOR2Cleared 510(K)
- K862810COMPANION 2500 PORTABLE VOLUME VENTILATOR2Cleared 510(K)
- K8626047200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT2Cleared 510(K)
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- K861707MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR2Cleared 510(K)
- K862025ENGSTROM ERICA II RESPIRATOR2Cleared 510(K)
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- K861488COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM2Cleared 510(K)
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- K860675COMPANION 2800 VOLUME VENTILATOR REMOT ALARM2Cleared 510(K)
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- K843424MICROPROCESSOR 7200A VENTILATOR2Cleared 510(K)
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- K842363PENLON ANESTHESIA VENTILATOR SERIES 3002Cleared 510(K)
- K841818IMPULSE VENTILATOR2Cleared 510(K)
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- K841279BEAR 332Cleared 510(K)
- K841393AB MANUAL VENTILATION ACCESS. 900C2Cleared 510(K)
- K8417577200 MICROPROCESSOR VENTILATOR2Cleared 510(K)
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- K833982MODEL IV 100B-DA INFANT VENTILATOR2Cleared 510(K)
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- K832508VOLUME VENTILATOR2Cleared 510(K)
- K833786MICROPROCESSOR VENTILATOR 72002Cleared 510(K)
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- K832467PORTABLE LIFECARE VENTILATOR PLV-1002Cleared 510(K)
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- K822456OHIO V5A ANESTHESIA VENTILATOR2Cleared 510(K)
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- K812961SHEFFIELD INFANT VENTILATOR MARK 42Cleared 510(K)
- K820393ANESTHESIA VENTILATOR2Cleared 510(K)
- K820220VENTILATOR MODELS2Cleared 510(K)
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- K812958EAST-FREEMAN VENTILATOR MARK 22Cleared 510(K)
- K812016VS600 JET VENTILATOR2Cleared 510(K)
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- K802168DRAGER AV2 ANESTHESIA VENTILATOR2Cleared 510(K)
- K802583INFANT VENTILATOR, (RESPIRATOR) PLAN B2Cleared 510(K)
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- K802270PROTECTIVE BAR FOR THE MA-1VENTILATOR2Cleared 510(K)
- K802118BEAR 2 ADULT VOL. VENTILATOR2Cleared 510(K)
- K802087BABYBIRD 2 VENTILATOR2Cleared 510(K)
- K802051NEWBOURNS INFANT VENTILATOR2Cleared 510(K)
- K801697MODEL BP-200 INFANT PRESSURE VENTILATOR2Cleared 510(K)
- K800999CAM-10 EXSUFFLATION BELT #11-0012Cleared 510(K)
- K800650MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM2Cleared 510(K)
- K800114SIEMENS-ELEMA AB MANUAL VENTILATION2Cleared 510(K)
- K792459PNEUPAC VENTILATOR/RESUSCITATOR2Cleared 510(K)
- K792456PNEUPAC VENTILATOR/RESUSCITATOR #32Cleared 510(K)
- K792455PNEUPAC VENTILATOR/RESUSCITATOR #22Cleared 510(K)
- K800125VENTILATOR TEST LUNG2Cleared 510(K)
- K792564MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR2Cleared 510(K)
- K791713VICKERS MEDICAL MODEL 130 NEAVENT-NEO2Cleared 510(K)
- K791186MODEL BP-2000 TIME-CYCLED VENTILATOR2Cleared 510(K)
- K791188CAM-10 BATTERY PACK (#7-001)2Cleared 510(K)
- K791033CAM-10 PVV PORTABLE VOLUME VENTILATOR2Cleared 510(K)
- K790605RESPIRAOTR, CAM-10 RBL2Cleared 510(K)
- K790809VS, ANESTHESIA VENTILATOR2Cleared 510(K)
- K790732VENTIMETER CONTROLLER2Cleared 510(K)
- K790733VENTIMETER VENTILATOR2Cleared 510(K)
- K790199VENTILATOR MODEL BV-300 INFANT2Cleared 510(K)
- K782074VENTILATOR, MODEL AVA-1, ADULT2Cleared 510(K)
- K781926VENTILATOR, INFANT MODEL 1002Cleared 510(K)
- K781160VENTILATOR, MINILUNG2Cleared 510(K)
- K781159VENTILATOR, PRESSURE2Cleared 510(K)
- K781161RESPIRATOR, BANTAM MODEL2Cleared 510(K)
- K780188INFANT VENTILATOR MODEL 1002Cleared 510(K)
- K772065CRITICAL CARE VENTILATOR 22Cleared 510(K)
- K771039RESPIRATOR, PROTABLE, VOLUME CONTROLLED2Cleared 510(K)
- K770132MODEL LP-3 PORTABLE VOLUME VENTILATOR2Cleared 510(K)
- K760663MVP-10 PEDIATRIC/NEONATAL VENTILATOR2Cleared 510(K)
- 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
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K070594
- 510(k) Type
- Traditional
- Applicant
- PULMONETIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/1/2007
- Days to Decision
- 152 days
- Submission Type
- Summary