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
- 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
- K251534Oxygen Concentrator (J10A)2Cleared 510(K)
- K252616Portable oxygen concentrator (JLO-190P)2Cleared 510(K)
- K251764Oxygen Concentrator-P2-O5E2Cleared 510(K)
- K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)2Cleared 510(K)
- K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)2Cleared 510(K)
- K251607Oxygen Concentrator (J5A)2Cleared 510(K)
- K243833Portable oxygen concentrator (JAY-1000P)2Cleared 510(K)
- K250625Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))2Cleared 510(K)
- K251130Portable Oxygen Concentrator (JM-P50A)2Cleared 510(K)
- K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)2Cleared 510(K)
- K242736Portable Oxygen Concentrator (Spirit-3)2Cleared 510(K)
- K242718Portable Oxygen Concentrator (P2-TOC)2Cleared 510(K)
- K240840Oxygen Concentrator (ZY-10AB/115)2Cleared 510(K)
- K240561Rugged Oxygen Generator (ROG) (RO01-00001)2Cleared 510(K)
- K230969Oxygen Concentrator2Cleared 510(K)
- K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)2Cleared 510(K)
- K223740Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)2Cleared 510(K)
- K222920Oxygen concentrator2Cleared 510(K)
- K230052Inogen Rove 62Cleared 510(K)
- K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)2Cleared 510(K)
- K211056Oxus Sieve Beds2Cleared 510(K)
- K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A2Cleared 510(K)
- K222086Inogen Rove 4 Portable Oxygen Concentrator2Cleared 510(K)
- K213210Oxygen Concentrator, Model JAY-5AW2Cleared 510(K)
- K210371Portable Oxygen Concentrator, model: P2-E62Cleared 510(K)
- K202389Oxygen Concentrator2Cleared 510(K)
- K203210Invacare Platinum 5NXG Oxygen Concentrator2Cleared 510(K)
- K203086X-PLO2R2Cleared 510(K)
- K200890Invacare Perfecto2V Oxygen Concentrator2Cleared 510(K)
- K200496Aer X2Cleared 510(K)
- K191875Owgels Oxygen Concentrator2Cleared 510(K)
- K192693Nuvo Nano Portable Oxygen Concentrator2Cleared 510(K)
- K190304Kingon P2 Oxygen Concentrator2Cleared 510(K)
- K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity2Cleared 510(K)
- K180837CONTEC Oxygen Concentrator2Cleared 510(K)
- K182454O2 Concepts Oxlife Independence Model 301-00012Cleared 510(K)
- K172234Oxygen Concentrator2Cleared 510(K)
- K172648Drive DeVilbiss iGo 2 Portable Oxygen Concentrator2Cleared 510(K)
- K162433GCE Zen-O Portable Oxygen Concentrator2Cleared 510(K)
- K160630Invacare Platinum Mobile Oxygen Concentrator2Cleared 510(K)
- K150930Deployable Oxygen Generation System-Smaill (DOGS-S)2Cleared 510(K)
- K141967PUREFILL OXYGEN COMPRESSOR2Cleared 510(K)
- K131968LONGFIAN OXYGEN CONCENTRATOR2Cleared 510(K)
- K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)2Cleared 510(K)
- K132205ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM2Cleared 510(K)
- K1340232300 SERIES MGO PORTABLE OXYGEN2Cleared 510(K)
- K131990OXYGEN GENERATOR LIQUEFIER - (OGL)2Cleared 510(K)
- K131016ROGS2Cleared 510(K)
- K123738MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD2Cleared 510(K)
- K120785OMNI 3 OXYGEN SYSTEM2Cleared 510(K)
- K121260TROOPER OXYGEN CONCENTRATOR2Cleared 510(K)
- K120566O2PAK OXYGEN GENERATOR2Cleared 510(K)
- K121531A&J 5L POCA SERIES OXYGEN CONCENTRATOR2Cleared 510(K)
- K121167CAIRE COMPANION 5 OXYGEN CONCENTRATOR2Cleared 510(K)
- K113317LIFECHOICE OXYGEN CONCENTRATOR2Cleared 510(K)
- K111885SIMPLYGO PORTABLE OXYGEN CONCENTRATOR2Cleared 510(K)
- K103563PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 41502Cleared 510(K)
- K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L2Cleared 510(K)
- K102750O2-IN-A-BOX, O2-IN-A-BOX2Cleared 510(K)
- K100957DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION2Cleared 510(K)
- K100920MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES2Cleared 510(K)
- K102245CARE ZY5BA OXYGEN CONCENTRATOR2Cleared 510(K)
- K091716MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY2Cleared 510(K)
- K093308MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD2Cleared 510(K)
- K092636POGS, MODEL 65/1302Cleared 510(K)
- K091541MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES2Cleared 510(K)
- K091650AXS-590 SERIES2Cleared 510(K)
- K091191GAS TRANSFILL2Cleared 510(K)
- K083163OMNI 2 OXYGEN SYSTEM2Cleared 510(K)
- K083559YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B2Cleared 510(K)
- K090007JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-070002Cleared 510(K)
- K091028OMNI 5 TOTAL O2 DELIVERY SYSTEM2Cleared 510(K)
- K083751INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC1002Cleared 510(K)
- K082566MARK 5 NUVO LITE OCSI AND STD2Cleared 510(K)
- K072348PRECISION OXYGEN CONCENTRATOR2Cleared 510(K)
- K081267HYGEIA-5 OXYGEN CONCENTRATOR2Cleared 510(K)
- K081508HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN2Cleared 510(K)
- K081468DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES2Cleared 510(K)
- K081206HOMELOX2Cleared 510(K)
- K080082OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS2Cleared 510(K)
- K080391DRIVE SOLSTICE OXYGEN CONCENTRATOR2Cleared 510(K)
- K072688LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY10002Cleared 510(K)
- K071608A&J POCA01 OXYGEN CONCENTRATOR2Cleared 510(K)
- K073242PORTABLE OXYGEN CONCENTRATOR, MODEL RS-004002Cleared 510(K)
- K071928THE INVACARE FLYER, MODEL IPC 1002Cleared 510(K)
- K071904DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)2Cleared 510(K)
- K071397DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES2Cleared 510(K)
- K071461MODEL 300D HOME OXYGEN LIQUEFIER2Cleared 510(K)
- K063454POGS, MODEL 33C2Cleared 510(K)
- K061414EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD2Cleared 510(K)
- K062153PORTABLE OXYGEN GENERATOR SYSTEM2Cleared 510(K)
- K061261L4 OXYGEN CONCENTRATOR2Cleared 510(K)
- K060922OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF52Cleared 510(K)
- K053230MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS2Cleared 510(K)
- K053229MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS2Cleared 510(K)
- K053240DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES2Cleared 510(K)
- K052396OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 6152Cleared 510(K)
- K043520EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR2Cleared 510(K)
- K033405LONGFEI LFY-I-5 OXYGEN CONCENTRATOR2Cleared 510(K)
- K051887PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)2Cleared 510(K)
- K033863OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-032Cleared 510(K)
- K050430MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR2Cleared 510(K)
- K042944HOME-AWAY SYSTEM, MODEL 10412Cleared 510(K)
- K043006MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M106052Cleared 510(K)
- K043615OXYTEC, MODEL 9002Cleared 510(K)
- K042262INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-102Cleared 510(K)
- K041664PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C2Cleared 510(K)
- K032818INOGEN ONE OXYGEN CONCENTRATOR2Cleared 510(K)
- K040738MOBILE OXYGEN STORAGE TANK (MOST)2Cleared 510(K)
- K040892MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 9052Cleared 510(K)
- K032509MARK 5 NUVO (M5C5)2Cleared 510(K)
- K030920POGS 332Cleared 510(K)
- K030233TRAVELSOME STANDARD2Cleared 510(K)
- K022684PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)2Cleared 510(K)
- K021685VENTURE HOMEFILL II WITH OXYGEN CONSERVER2Cleared 510(K)
- K020386INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX022Cleared 510(K)
- K021082ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.02Cleared 510(K)
- K020330DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)2Cleared 510(K)
- K013931OMNI OXYGEN SYSTEM, MODEL 10002Cleared 510(K)
- K020324LIFESTYLE OXYGEN CONCENTRATOR2Cleared 510(K)
- K020362P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM2Cleared 510(K)
- K014301MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS2Cleared 510(K)
- K013223PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)2Cleared 510(K)
- K012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS0092Cleared 510(K)
- K014078ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM2Cleared 510(K)
- K004047HOME-AWAY SYSTEM2Cleared 510(K)
- K013472TOTAL O22Cleared 510(K)
- K011844MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS2Cleared 510(K)
- K003472INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM2Cleared 510(K)
- K003939VENTURE HOME FILL II, MODEL IOH 2002Cleared 510(K)
- K991722DEVILBISS 5 LITER OXYGEN CONCENTRATOR2Cleared 510(K)
- K983627VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM2Cleared 510(K)
- K993088PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI2Cleared 510(K)
- K981047FRESH AIR2Cleared 510(K)
- K991569HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O22Cleared 510(K)
- K984081EMOX2Cleared 510(K)
- K983777MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM2Cleared 510(K)
- K982243CANOGEN PORTABLE OXYGEN GENERATOR MODEL 6152Cleared 510(K)
- K981078TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 10002Cleared 510(K)
- K972614TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 6052Cleared 510(K)
- K971889CHAD TOTAL O2 DELIVERY SYSTEM2Cleared 510(K)
- K971947INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)2Cleared 510(K)
- K971964OXLIFE EXCELL OXYGEN CONCENTRATORS2Cleared 510(K)
- K971129OXYPURE PORTABLE OXYGEN GENERATOR2Cleared 510(K)
- K960309AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)2Cleared 510(K)
- K963042INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M4070018532Cleared 510(K)
- K954506EMOX2Cleared 510(K)
- K955549OXLIFE OXYGEN CONCENTRATORS2Cleared 510(K)
- K952941SUN MODEL OA 3000 OXYGEN ANALYZER2Cleared 510(K)
- K954271WESTMED CONDESATE COLLECTION TRAP2Cleared 510(K)
- K9538155 LPM OXYGEN CONCENTRATOR2Cleared 510(K)
- K953949HUMIDIFIER & ACCESSORIES2Cleared 510(K)
- K951882ECO CHECK (ECOVALVE AND OXYGEN MONITOR)2Cleared 510(K)
- K941145OXY-GENERATOR2Cleared 510(K)
- K9520373 LPM OXYGEN CONCENTRATOR2Cleared 510(K)
- K952268MODEL DELTA, OM OXYGEN CONCENTRATOR2Cleared 510(K)
- K942082MODEL 6323 OXYGEN CONCENTRATOR2Cleared 510(K)
- K933081OXLIFE OXYGEN CONCENTRATOR2Cleared 510(K)
- K924565SBS MODEL 16152Cleared 510(K)
- K935370MINIOX IA OXYGEN ANALYZER2Cleared 510(K)
- K942357H-500 ALLIANCE OXYGEN CONCENTRATOR2Cleared 510(K)
- K931355WHISPER O22Cleared 510(K)
- K924818MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES2Cleared 510(K)
- K924152KEYSTONE CONCENTRATOR, MODEL PV5L2Cleared 510(K)
- K924100OXYGEN CONCENTRATOR2Cleared 510(K)
- K923650SCOTTY2Cleared 510(K)
- K924146OH-500 OXYGEN CONCENTRATOR2Cleared 510(K)
- K914916ALPINE V2Cleared 510(K)
- K914488MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS2Cleared 510(K)
- K915381PORTABLE OXYGEN GENERATOR2Cleared 510(K)
- K912794ECONOMATE/PATRIOT2Cleared 510(K)
- K913327CONTEMPRO2 HOME HEALTH CARE REGULATOR2Cleared 510(K)
- K904639GENOX MODEL CT-12Cleared 510(K)
- K901712GUILD MAXOX GENERATOR (MAXOX)2Cleared 510(K)
- K904087MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON2Cleared 510(K)
- K904271OXLIFE2Cleared 510(K)
- K903608V-LINK2Cleared 510(K)
- K904002GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST2Cleared 510(K)
- K903411FIELD MEDICAL OXYGEN GEN/DIST SYS-BATTLEFIELD PURP2Cleared 510(K)
- K902890ASPEN 3 OXYGEN CONCENTRATOR2Cleared 510(K)
- K896457DEVILBISS MODEL PV02 SERIES2Cleared 510(K)
- K895177PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR2Cleared 510(K)
- K895141MODEL 590 OXYGEN CONCENTRATOR2Cleared 510(K)
- K894384K.E.E. OXYGEN CONCENTRATOR2Cleared 510(K)
- K891488MOBILAIRE V OXYGEN CONCENTRATOR2Cleared 510(K)
- K884563OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%2Cleared 510(K)
- K884018LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT2Cleared 510(K)
- K890150H-3000 OXYGEN CONCENTRATOR2Cleared 510(K)
- K884581RELIANT OXYGEN CONCENTRATOR2Cleared 510(K)
- K883837MIKADO AC 4052Cleared 510(K)
- K884084PORTABLE OXYGEN GENERATOR2Cleared 510(K)
- K883591MARK-5 CONCENTRATOR2Cleared 510(K)
- K881802ALPINE PORTABLE OXYGEN GENERATOR2Cleared 510(K)
- K880044OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-82Cleared 510(K)
- K873526PALL FIELD MEDICAL OXYGEN GENERA. & DISTRI. SYSTEM2Cleared 510(K)
- K880261MOBILE PAK, MODEL AC2Cleared 510(K)
- K880262MOBILE PAK, MODEL DC2Cleared 510(K)
- K873156AMOX OXYGEN GENERATORS2Cleared 510(K)
- K873284OXYGEN/STERILE AIR GEN SYST/SURGICAL HANDPIECES2Cleared 510(K)
- K8725344LYF OXYGEN CONCENTRATOR2Cleared 510(K)
- K873071BUNN CONCENTRATOR MODEL 2100 SERIES2Cleared 510(K)
- K871603CRITERION II & IIA OXYGEN CONCENTRATORS2Cleared 510(K)
- K872470DEVO/MC44 OXYGEN CONCENTRATOR2Cleared 510(K)
- K870064MOBIL-AIR2Cleared 510(K)
- K864005ALPINE2Cleared 510(K)
- K864045PORTABLE OXYGEN GENERATOR2Cleared 510(K)
- K861435BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE2Cleared 510(K)
- K862194INHALATOR MODELS 8100, 10100 AND 102002Cleared 510(K)
- K861012SILENT PARTNER MODEL 10-10012Cleared 510(K)
- K861011SILENT PARTNER MODEL 10-20012Cleared 510(K)
- K854748TRAVELPAK MODEL DC-2022Cleared 510(K)
- K855208BUNN LITE OXYGEN CONCENTRATOR2Cleared 510(K)
- K860060RX02 PLUS OXYGEN CONCENTRATOR2Cleared 510(K)
- K854509TRAVELPAK MODEL AC-1022Cleared 510(K)
- K854374OXYGEN CONCENTRATOR, MODEL BX-50002Cleared 510(K)
- K853004PORTABLE OXYGEN UNIT2Cleared 510(K)
- K852144SIERRA -OXYGEN CONCENTRATE2Cleared 510(K)
- K851434MOBILAIRE III P3 OXYGEN CONCENTRATOR2Cleared 510(K)
- K851437PRIME AIRE O2 PLUS 22Cleared 510(K)
- K851435PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR2Cleared 510(K)
- K851439MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR2Cleared 510(K)
- K851438MOBILAIRE II(P2A) OXYGEN CONCENTRATOR2Cleared 510(K)
- K852209DEVO/MC29 OXYGEN CONCENTRATOR MC29D2Cleared 510(K)
- K850346OXYGEN CONCENTRATOR2Cleared 510(K)
- K850253ECONO MATE -OXYGEN CONCENTRATOR2Cleared 510(K)
- K844852THE GENERIC OXYGEN CONCENTRATOR2Cleared 510(K)
- K844312ME-TOO OXYGEN CONCENTRATOR2Cleared 510(K)
- K844223PREMIER O2 OXYGEN CONCENTRATOR2Cleared 510(K)
- K844328OXYGEN CONCENTRATOR2Cleared 510(K)
- K843691PORTABLE OXYGEN UNIT2Cleared 510(K)
- K843715ECONO MATE2Cleared 510(K)
- K843811BUNN 3001 OXYGEN CONCENTRATOR2Cleared 510(K)
- K843243COMPANION 492 OXYGEN CONCENTRATOR2Cleared 510(K)
- K842753OXYGEN CONCENTRATOR2Cleared 510(K)
- K842114CONCENTRACTORS2Cleared 510(K)
- K841102BUNN 1000 OXYGEN CONCENTRATOR2Cleared 510(K)
- K834274CRITERION I2Cleared 510(K)
- K833938CATALOG 6400 OXYGEN CONCENTRATOR2Cleared 510(K)
- K833495BUNN MICRO OXYGEN CONCENTRATOR2Cleared 510(K)
- K833500MAX 02 OXYGEN CONCENTRATOR2Cleared 510(K)
- K831819OXYGEN CONCENTRATOR RESPIRATORY SUPPOR2Cleared 510(K)
- K830324AIRCARE 3002Cleared 510(K)
- K830174DE VO/44 OXYGEN CONCENTRATOR #4442Cleared 510(K)
- K830046MODEL HI-FLO2 OXYGEN RICH AIR SUPPLY2Cleared 510(K)
- K823172MEDOX OXYGEN SYSTEM2Cleared 510(K)
- K823582OXYGEN CONCENTRATOR UCC-1002Cleared 510(K)
- K823524OXYGEN CONCENTRATOR2Cleared 510(K)
- K822889MODEL #6200 OXYGEN CONCENTRATOR2Cleared 510(K)
- K822871MODEL BX-3000 OXYGEN CONCENTRATOR2Cleared 510(K)
- K822789ROOMATE II2Cleared 510(K)
- K822301ROYAL 1 OXYGEN CONCENTRATOR2Cleared 510(K)
- K821393SYSTEM ONE OXYGEN CONCENTRATOR2Cleared 510(K)
- K821520MODEL 379 FLOW/DIVIDER2Cleared 510(K)
- K813436OXYCON2Cleared 510(K)
- K813320MODEL 6200 OXYGEN CONCENTRATOR2Cleared 510(K)
- K813058PORTABLE OXYGEN GENERATOR2Cleared 510(K)
- K813018OXYTRON OXYGEN GENERATOR2Cleared 510(K)
- K812282PORTABLE OXYGEN GENERATOR2Cleared 510(K)
- K812693LIF-O-GEN #3000 OXYGEN CONCENTRATOR2Cleared 510(K)
- K812513MINI O22Cleared 510(K)
- K811155MODEL RXO2 OXYGEN RICH AIR SUPPLY2Cleared 510(K)
- K810411PORTABLE OXYGEN GENERATOR2Cleared 510(K)
- K810272BIO CARE OXYGEN CONCENTRATOR2Cleared 510(K)
- K803232COMPRESSED AIR & OXYGEN GEN./DELIVERY SY2Cleared 510(K)
- K802426RESPO2 OXYGEN CONCENTRATOR2Cleared 510(K)
- K801523MODEL 379 WXYGEN CONCENTRATOR2Cleared 510(K)
- K801104ROOMMATE-OXYGEN CONCENTRATOR2Cleared 510(K)
- K792385DEVO OXYGEN CONCENTRATOR, MODEL 9552Cleared 510(K)
- K792149MTC OXYGEN CONCENTRATOR, OR PRIME-AIRE2Cleared 510(K)
- K791437LINDE OXYGEN CONCENTRATOR LOC-II2Cleared 510(K)
- K791043LINDE OXYGEN CONCENTRATOR MODEL LOC-HC2Cleared 510(K)
- K790520AIRCARE OXYGEN GENERATOR2Cleared 510(K)
- K781300OXYGEN CONCENTRATOR2Cleared 510(K)
- K781074OXYGEN RICH AIR SUPPLY UNIT-MODEL 3902Cleared 510(K)
- K780862MODEL 290 OXYGEN RICH AIR SUPPLY UNIT2Cleared 510(K)
- K780366SOLID-OX EMERGENCY OXYGEN2Cleared 510(K)
- K780020GENERATOR, OXYGEN, PORTABLE2Cleared 510(K)
- K771761SOLID OXYGEN SYSTEM2Cleared 510(K)
- K771665OXYGEN CONCENTRATOR2Cleared 510(K)
- K770157DEVILBISS OXYGEN ENRICHER2Cleared 510(K)
- K761213AIR ENRICHER2Cleared 510(K)
- K760704OXYGEN-RICH2Cleared 510(K)
- K760705OXYGEN-RICH2Cleared 510(K)
- 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
- SDSCompression-Based Airway Clearance Device2Product Code
- SDTIntra-Pulmonary Percussive Vibration (Ipv) Devices2Product Code
- SFPVentilator-Compatible Nebulizer2Product Code
- SGRNoninvasive Positive Airway Pressure System, Facility Use2Product 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
MARK 5 NUVO LITE OCSI AND STD
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K082566
- 510(k) Type
- Abbreviated
- Applicant
- Nidek Medical Products, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/3/2008
- Days to Decision
- 90 days
- Submission Type
- Summary