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
- K221841EOlife®2Cleared 510(K)
- K212905Sotair Device2Cleared 510(K)
- K210288Disposable Manual Resuscitator2Cleared 510(K)
- K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH202Cleared 510(K)
- K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer2Cleared 510(K)
- K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator2Cleared 510(K)
- K132172NEONATALIE RESUSCITATOR2Cleared 510(K)
- K112852BABI PLUS NEONATAL RESUSCITATION BAG2Cleared 510(K)
- K102824AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC2Cleared 510(K)
- K102649NEOPOP INFANT RESUSCITATOR WITH FLOW METER2Cleared 510(K)
- K094003REVIVATOR2Cleared 510(K)
- K093081POCKET BVM2Cleared 510(K)
- K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE2Cleared 510(K)
- K073410SAVE RESUSCITATOR2Cleared 510(K)
- K073171RESUSCITATION TIMER, MODEL L770-CPR2Cleared 510(K)
- K072021NEOPIP INFANT RESUSCITATOR2Cleared 510(K)
- K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM2Cleared 510(K)
- K062080RESUSCITATION TIMER, MODEL L770-CPR2Cleared 510(K)
- K053466HSINER RESUSCITATOR2Cleared 510(K)
- K053140AMBU MARK IV RESUSCITATOR2Cleared 510(K)
- K053142AMBU MARK IV BABY RESUSCITATOR2Cleared 510(K)
- K051177PVC AND SILICONE MANUAL RESUSCITATORS2Cleared 510(K)
- K042556SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,2Cleared 510(K)
- K042682AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR2Cleared 510(K)
- K042843AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS2Cleared 510(K)
- K032596STURDY MANUAL RESUSCITATOR2Cleared 510(K)
- K031395MERLIN RESUSCITATOR2Cleared 510(K)
- K031434BAWMED E-Z BAG RESUSCITATOR2Cleared 510(K)
- K030864VADI MANUAL RESUSCITATOR2Cleared 510(K)
- K021328SMART BAG MO2Cleared 510(K)
- K0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR2Cleared 510(K)
- K023494NELLCOR INDGO MANUAL RESUSCITATOR2Cleared 510(K)
- K021446OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR2Cleared 510(K)
- K021716SIMPLIFY COMPACT RESUSCITATOR2Cleared 510(K)
- K021390PMX COMPACT RESUCITATOR2Cleared 510(K)
- K012271ACUTEVENTILATOR2Cleared 510(K)
- K014071PMX DISPOSABLE BAG MASK RESUSCITATOR2Cleared 510(K)
- K021442OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR2Cleared 510(K)
- K0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX2Cleared 510(K)
- K012842V*CARE MANUAL RESUSCITATOR2Cleared 510(K)
- K003927Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH022Cleared 510(K)
- K002846HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR2Cleared 510(K)
- K993278AMBU NEONATE SILICONE RESUSCITATOR2Cleared 510(K)
- K993194RUSCH MANUAL RESUSCITATOR BAG2Cleared 510(K)
- K9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE2Cleared 510(K)
- K992057IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,0080062Cleared 510(K)
- K991955MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION2Cleared 510(K)
- K991953MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION2Cleared 510(K)
- K982215MANUAL RESUSCITATOR WITH ACE2Cleared 510(K)
- K980066CPR FILTERSHIELD2Cleared 510(K)
- K981308INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG2Cleared 510(K)
- K981307INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR2Cleared 510(K)
- K974141PLUS REUSABLE RESUSCITATOR2Cleared 510(K)
- K973419DMR PLUS DISPOSABLE MANUAL RESUSCITATOR2Cleared 510(K)
- K973106GOLEMB DISPOSABLE BAG MASK RESUSCITATOR2Cleared 510(K)
- K971243OHMEDA INFANT RESUSCITATION SYSTEM2Cleared 510(K)
- K970756MERCURY MEDICAL REUSABLE CPR BAG2Cleared 510(K)
- K972283SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT2Cleared 510(K)
- K972139ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP2Cleared 510(K)
- K963848MANUAL RESUSCITATOR2Cleared 510(K)
- K970991DATEX ENGSTOM MANUAL RESUSCITATOR2Cleared 510(K)
- K970959INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)2Cleared 510(K)
- K964584AMBU SPUR NEONATE2Cleared 510(K)
- K964719HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR2Cleared 510(K)
- K955507GRAYCO POCKET PUMP2Cleared 510(K)
- K961330BAGRIGHT INFANT RESUSCITATOR2Cleared 510(K)
- K961329BAGRIGHT CHILD RESUSCITATOR2Cleared 510(K)
- K961882RESPOSABLE INFANT RESUSCITATOR2Cleared 510(K)
- K961868RESPOSABLE CHILD RESUSCITATOR2Cleared 510(K)
- K961369BAGRIGHT RESPOSABLE RESUSCITATOR2Cleared 510(K)
- K961332BAGRIGHT RESPOSABLE INFANT RESUSCITATOR2Cleared 510(K)
- K961331BAGRIGHT RESPOSABLE CHILD RESUSCITATOR2Cleared 510(K)
- K960468DMR/CO2 COMBO KTI2Cleared 510(K)
- K953546MANUAL PULMONARY RESUSICITATOR2Cleared 510(K)
- K954866MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR2Cleared 510(K)
- K954296BAGRIGHT RESUSCITATOR2Cleared 510(K)
- K954150VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)2Cleared 510(K)
- K953617RESPOSABLE RESUSCITATOR2Cleared 510(K)
- K953824LIFEMASK FACE SHIELD2Cleared 510(K)
- K952512CAPNO-FLO REGULATOR, CAPNO-FLO2Cleared 510(K)
- K952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC2Cleared 510(K)
- K934699RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE2Cleared 510(K)
- K944301HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 53802Cleared 510(K)
- K944347PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)2Cleared 510(K)
- K921982MATRX HOPE(R) 5 RESUSCITATOR2Cleared 510(K)
- K941037BNOS MICRO VENT, MODEL AC AND MODEL AO2Cleared 510(K)
- K943617DISPOSABLE MANUAL RESUSCITATOR2Cleared 510(K)
- K940581BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS2Cleared 510(K)
- K934310BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR2Cleared 510(K)
- K922819INFANT DISPOSABLE BAG MASK RESUSCITATOR2Cleared 510(K)
- K922691LSP (MODEL 554) BAG MASK RESUSCITATOR2Cleared 510(K)
- K933626CAPNO-FLO2Cleared 510(K)
- K932797PRESSURE LIMITING ELBOW2Cleared 510(K)
- K924671BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT2Cleared 510(K)
- K924610BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT2Cleared 510(K)
- K930429AID, CARDIOPULMONARY RESUSCITATION2Cleared 510(K)
- K923762SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE2Cleared 510(K)
- K913474RESPIRE DISPOSABLE PULMONARY RESUSCITATOR2Cleared 510(K)
- K922810ODYSSEY2Cleared 510(K)
- K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)2Cleared 510(K)
- K921553LSPI INFANT BAG MASK2Cleared 510(K)
- K921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED2Cleared 510(K)
- K924217LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED2Cleared 510(K)
- K924216AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO2Cleared 510(K)
- K924215AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR2Cleared 510(K)
- K922712SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM2Cleared 510(K)
- K922707SPUR ADULT WITH OPEN RESERVOIR SYSTEM2Cleared 510(K)
- K922004MODIFICATION PURITAN-BENNETT INFANT PM22Cleared 510(K)
- K915810MER BAG2Cleared 510(K)
- K920570PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED2Cleared 510(K)
- K913900V*CARE MANUAL RESUSCITATOR, CAT#VR-10002Cleared 510(K)
- K912620OPOMAT MANUAL RESUSCITATOR VENTILATOR2Cleared 510(K)
- K912203EMS SINGLE USE MANUAL RESUSCITATORS2Cleared 510(K)
- K914196RONDEX MASKS MODELS 9015/9011/901102 MODIFIED2Cleared 510(K)
- K914187AMBU SILICONE RESUSCITATOR INFANT/CHILD2Cleared 510(K)
- K913370MODIFICATION MANUAL RESUSCITATOR (PMR 2)2Cleared 510(K)
- K911971MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.2Cleared 510(K)
- K912625MOUTH TO MASK RESUSCITATOR2Cleared 510(K)
- K904899VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR2Cleared 510(K)
- K911298PRESSURE LIMITING ELBOW WITH MANOMETER PORT2Cleared 510(K)
- K910856MANUAL RESUSCITATOR2Cleared 510(K)
- K910040AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT2Cleared 510(K)
- K911622CPR BAG2Cleared 510(K)
- K905304DRESSER ARGUS P/N 18182Cleared 510(K)
- K905002SINGLE USE MANUAL RESUSCITATORS2Cleared 510(K)
- K904346BAUMAN CPR/RESUSCITATOR2Cleared 510(K)
- K9027331ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR2Cleared 510(K)
- K903631INFANT MANUAL RESUSCITATOR (PMR 2)2Cleared 510(K)
- K903570SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC2Cleared 510(K)
- K903438MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS2Cleared 510(K)
- K903443MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR2Cleared 510(K)
- K902261AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT2Cleared 510(K)
- K9005771ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)2Cleared 510(K)
- K900260AMBU LIFE KEY AND AMBU RES-CUE KEY2Cleared 510(K)
- K901218LIFE AID RESUSCITATOR2Cleared 510(K)
- K900349PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER2Cleared 510(K)
- K895820RESUSO MASK2Cleared 510(K)
- K895589MANUAL RESUSCITATOR2Cleared 510(K)
- K896886ARTEC RESPOND PULMONARY RESUSCITATOR2Cleared 510(K)
- K895351RESPIRONICS INFANT BAGEASY2Cleared 510(K)
- K895169MANUAL DISPOSABLE PULMONARY RESUSCITATOR2Cleared 510(K)
- K894365SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR2Cleared 510(K)
- K885243NEOVO2R VENTILATORY2Cleared 510(K)
- K892221PULMONARY RESUSCITATOR, MODIFICATION2Cleared 510(K)
- K881881OXYGENATION CATHETER2Cleared 510(K)
- K881483AIRWAY-CIRCULATION EVALUATOR2Cleared 510(K)
- K884526ADULT RESUSCITATOR WITH MASK AND FILTER2Cleared 510(K)
- K884068PULMANEX TM (NEO-NATAL SIZE)2Cleared 510(K)
- K883434AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)2Cleared 510(K)
- K882285NONREBREATHING CIRCUIT2Cleared 510(K)
- K881207RES-Q 1, 2, 3, 4 AND 52Cleared 510(K)
- K881686CPR BAG2Cleared 510(K)
- K882278RESUSCITATION BAG CONTROLLER (RBC)2Cleared 510(K)
- K881086LIFEGUARD MOUTH TO MASK RESUSCITATOR2Cleared 510(K)
- K881087LIFEGUARD SINGLE USE MANUAL RESUSCITATORS2Cleared 510(K)
- K880450RESUSCI PATIENT FACE SHIELD2Cleared 510(K)
- K880394FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR2Cleared 510(K)
- K874567RESUSCITATOR2Cleared 510(K)
- K874418LSP DISPOSABLE BAG RESUSCITATOR, MODEL 4702Cleared 510(K)
- K875077HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.2Cleared 510(K)
- K874321SOLCO SILICONE RESUSCITATOR2Cleared 510(K)
- K873286DISPOSABLE, MANUAL PULMONARY RESUSCITATOR2Cleared 510(K)
- K873043MOUTH TO FACE RESUSCITATOR2Cleared 510(K)
- K871147MODIFIED CPREVIVER2Cleared 510(K)
- K864308BAUMAN CPR/RESPIRATOR2Cleared 510(K)
- K864125CPREVIVER2Cleared 510(K)
- K863026PULMANEX TM (MODIFICATION)2Cleared 510(K)
- K860693PULMANEX (TM)2Cleared 510(K)
- K860180MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR2Cleared 510(K)
- K854037PULMANEX2Cleared 510(K)
- K851171COMBIBAG MANUAL RESUSCITATOR2Cleared 510(K)
- K852096RESUS-AID DISPOSABLE RESUSCITATION SHIELD2Cleared 510(K)
- K844729RESUSCITATOR, PULMONARY, MANUAL2Cleared 510(K)
- K850436STAT BLUE DISPOS. MANUAL RESUSCITATOR2Cleared 510(K)
- K844420MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR2Cleared 510(K)
- K843223FLOW CONTROLLER2Cleared 510(K)
- K842693RESPIRONICS VENTEASY2Cleared 510(K)
- K842696LIFE-MASK INFANT RESUSCITATOR2Cleared 510(K)
- K842487SAMSON'S NEWBORN LUNG INFLATOR 340-10002Cleared 510(K)
- K841496FRASER HARLAKE HOPE III RESUSCITATOR2Cleared 510(K)
- K840935MANUAL RESUSCITATION SYSTEM2Cleared 510(K)
- K840349MARK III RESUSCITATOR2Cleared 510(K)
- K834250RESCUE MASK2Cleared 510(K)
- K834400FLYNN III-CHILD BAG-MASK UNIT ETC2Cleared 510(K)
- K833244REVIVE2Cleared 510(K)
- K832495FLYNN SERIES III BAG/MASK UNIT-2Cleared 510(K)
- K831885CODE BLUE MANUAL RESUSCITATOR2Cleared 510(K)
- K831486SC-603 TWIN VALVE2Cleared 510(K)
- K831198CPR HEARTSAVER AND BREATHOLATOR2Cleared 510(K)
- K823710DISPOSABLE AIRWAY ADEJUNCT2Cleared 510(K)
- K823408BE#1000-INSTANT ON/OFF O2 VALVE2Cleared 510(K)
- K822213SIEMENS-ELEMA AB AGA REVIVATOR2Cleared 510(K)
- K822356MODULAIDE EMERG. CARDIAC LIFE SUPP. KT2Cleared 510(K)
- K820059RESUSCITATION MASK2Cleared 510(K)
- K812273RESUSCITATION CIRCUIT2Cleared 510(K)
- K812022ZEE MANUAL RESUSCITATOR2Cleared 510(K)
- K803066DISPOSABLE BAG MASK ADEJUNCT2Cleared 510(K)
- K802813PMR-2 PURITAN MANUAL RESUSCITATOR2Cleared 510(K)
- K802231AIR VIVA II2Cleared 510(K)
- K802081AULD BAGGER KIT2Cleared 510(K)
- K792118AIR-SHIELDS RESUSCITATORS2Cleared 510(K)
- K791468RESUSCI-BAG-VALVE2Cleared 510(K)
- K780216LIFESAVER, MANUAL #51602Cleared 510(K)
- K771350AMBU RESUSCITATOR2Cleared 510(K)
- K771175RESUSCITATOR, MS302Cleared 510(K)
- K761065NEONATAL RESUSCITATOR, SAMSON2Cleared 510(K)
- K761025BAG RESUSCITATOR2Cleared 510(K)
- 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
- 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
SMART BAG MO
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K021328
- 510(k) Type
- Traditional
- Applicant
- O-TWO SYSTEMS INTERNATIONAL INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/26/2003
- Days to Decision
- 426 days
- Submission Type
- Summary