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
- CBLAbsorbent, Carbon-Dioxide1Product Code
- CBNApparatus, Gas-Scavenging2Product Code
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)2Product Code
- CBPValve, Non-Rebreathing2Product Code
- K210992Altech® Exhalation Valve (Single Limb and Dual Limb)2Cleared 510(K)
- K192285CPR Face Shield2Cleared 510(K)
- K173770OJR215 Pressure Relief Manifold2Cleared 510(K)
- K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)2Cleared 510(K)
- K152521Seal Rite Non-Rebreathing Valve2Cleared 510(K)
- K142764KYOLING CPR Mask with Oxygen Port and Without Oxygen Port2Cleared 510(K)
- K142402BigEasy Non-Rebreathing Valve2Cleared 510(K)
- K132143EXHALATION VALVE2Cleared 510(K)
- K112126GENUINE FIRST AID CPR MASK2Cleared 510(K)
- K111191AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE2Cleared 510(K)
- K102299CPR FACE MASK2Cleared 510(K)
- K083418CPR MASK2Cleared 510(K)
- K091538PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-1002Cleared 510(K)
- K082345OXYGEN DEMAND VALVE2Cleared 510(K)
- K081516MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT2Cleared 510(K)
- K052458LIV MEDICA CPR FACE MASK2Cleared 510(K)
- K052743DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 49212Cleared 510(K)
- K042727POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A2Cleared 510(K)
- K031397MERLIN E-MASK2Cleared 510(K)
- K031431BAWMED RESCUE MASK2Cleared 510(K)
- K040366PRESSURE MANIFOLD, MODEL BC 1102Cleared 510(K)
- K030943MODIFICATION TO HIOX2Cleared 510(K)
- K023805LAERDAL PAEDIATRIC POCKET MASK, MODEL 8200502Cleared 510(K)
- K020665HI-OX2Cleared 510(K)
- K010191Y2000 POCKET RESCUE2Cleared 510(K)
- K001742RESUSCI INFLATE-A-SHIELD CPR BARRIER2Cleared 510(K)
- K993528RUSCH EMERGENCY MASK2Cleared 510(K)
- K991617FACE-2-FACE CPR PROTECTION SHIELD2Cleared 510(K)
- K983631AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P2Cleared 510(K)
- K983919EMS MOUTH TO MASK RESUSCITATORS2Cleared 510(K)
- K984481EXHALATION VALVE2Cleared 510(K)
- K980725EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)2Cleared 510(K)
- K980052RESPAIDE2Cleared 510(K)
- K981169RONDEX CPR ISO-SHIELD2Cleared 510(K)
- K973066NON-REBREATHING 'T' (BE 117)2Cleared 510(K)
- K970780ONE-WAY VALVE (WITH CONNECTOR)2Cleared 510(K)
- K960587CPROTECTOR 20002Cleared 510(K)
- K963755SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR2Cleared 510(K)
- K960995CPR BIO-BARRIER FACESHEILD2Cleared 510(K)
- K955520RESCUE BREATHER2Cleared 510(K)
- K954426CPR LIFE MASK COMPACT BARRIER2Cleared 510(K)
- K955634MONTGOMERY TRACHEOSTOMY SPEAKING VALVE2Cleared 510(K)
- K953414CPR MICROMASK WITH OXYGEN INLET2Cleared 510(K)
- K953349SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE2Cleared 510(K)
- K953230CPR SUPER POCKET PACK2Cleared 510(K)
- K953461CPR MASK & RELATED FAMILY KITS2Cleared 510(K)
- K951483CPR MICROMASK2Cleared 510(K)
- K940820PERSHIELD CPR DEVICE2Cleared 510(K)
- K9462253M FILTRETE(TM) AIR FILTER MEDIA2Cleared 510(K)
- K940503MOUTH-TO-MASK RESUSCITATOR2Cleared 510(K)
- K950770CPR MICROSHIELD II2Cleared 510(K)
- K950769CPR MICROMASK PLUS CATALOG NO 73-4022Cleared 510(K)
- K945822CAPNO-FLO(TM) REGULATOR2Cleared 510(K)
- K9503924-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 080502Cleared 510(K)
- K940712PPM III2Cleared 510(K)
- K943761NON-BREATHING VALVE2Cleared 510(K)
- K941008COMPLETE CPR KIT2Cleared 510(K)
- K9451774-O2 JR. (CPR MOUTH BARRIER)2Cleared 510(K)
- K943402K.P.R. (KING PERSONAL RESUSCITATOR)2Cleared 510(K)
- K942021MOUTH TO MOUTH BREATHER2Cleared 510(K)
- K933756MAGNASHIELD CPR MOUTH BARRIER2Cleared 510(K)
- K913163NON REBREATHING VALVE2Cleared 510(K)
- K914195RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED2Cleared 510(K)
- K902299CPR VALVE (NON-REBREATHING) MODEL #90302Cleared 510(K)
- K891124NON-REBREATHING AIRWAY AND MASK(S) KITS2Cleared 510(K)
- K884543LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK2Cleared 510(K)
- K883383LIFEGUARD VENT MASK2Cleared 510(K)
- K883988NON-REBREATHING TEE PIECE (NRTP)2Cleared 510(K)
- K881931RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR2Cleared 510(K)
- K882204RESUSCITATOR VALVE ASSEMBLY W/FILTER2Cleared 510(K)
- K873570LIFECARE EXHALATION VALVE #06-6992Cleared 510(K)
- K871367HY-FLOW NON-REBREATHING VALVE ASSEMBLY2Cleared 510(K)
- K864681CARHILL ONE-WAY RESUSCITATION VALVE2Cleared 510(K)
- K870895NO. 1552, VALVED VENTI-COMP2Cleared 510(K)
- K870382DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 30112Cleared 510(K)
- K870253INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR2Cleared 510(K)
- K8701381160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE2Cleared 510(K)
- K864472PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK2Cleared 510(K)
- K861401LAERDAL POCKET MASK2Cleared 510(K)
- K855218RONDEX CPR VALVE2Cleared 510(K)
- K833748RESCUE VALVE2Cleared 510(K)
- K832868RESUSCITATION VALVE2Cleared 510(K)
- K831246WHISTLER IN-LINE PRESSURE RELEASE VALVE2Cleared 510(K)
- K810348CM 32Cleared 510(K)
- K791908RETARD VALVE 3-STACK #M-5142Cleared 510(K)
- K791907RETARD VALVE 3-STACK #M-5152Cleared 510(K)
- K791849ONE-WAY VALVE-MALE, M-5042Cleared 510(K)
- K791850ONE-WAY VALVE-FEMALE, M-5032Cleared 510(K)
- K790820NON-REBREATHING T PIECE2Cleared 510(K)
- K790151ONE-WAY VALVE2Cleared 510(K)
- K781920VALVE, VENT-AWAY TWO-WAY2Cleared 510(K)
- K770629VALVE, EXHALATION BE 115-4, 115-52Cleared 510(K)
- K770627ADAPTER, VALVE, ONE WAY BE-130-222Cleared 510(K)
- 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
PPM III
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K940712
- 510(k) Type
- Traditional
- Applicant
- O-TWO SYSTEMS INTL., INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/14/1994
- Days to Decision
- 270 days
- Submission Type
- Statement