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
- 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
- K250322Respond OC Conserving Regulator (130-0800)2Cleared 510(K)
- K220591Proxima2Cleared 510(K)
- K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile2Cleared 510(K)
- K200401Apogee2Cleared 510(K)
- K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula2Cleared 510(K)
- K131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN2Cleared 510(K)
- K113111CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION2Cleared 510(K)
- K103392CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER2Cleared 510(K)
- K090421MODEL 350G GAS CONSERVER2Cleared 510(K)
- K070740CHAD THERAPEUTICS BONSAI MODEL 8002Cleared 510(K)
- K060751INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR2Cleared 510(K)
- K060382FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-12Cleared 510(K)
- K052563INOGEN SATELLITE CONSERVER, MODEL SC-1002Cleared 510(K)
- K051988OXY-SERVE II OXYGEN CONSERVING REGULATOR2Cleared 510(K)
- K051540INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR2Cleared 510(K)
- K051007ACCU02 SYSTEM2Cleared 510(K)
- K042142CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S2Cleared 510(K)
- K041057FLO-RITE2Cleared 510(K)
- K041568EOCD2Cleared 510(K)
- K033197INOGEN SATELLITE CONSERVER2Cleared 510(K)
- K033364CHAD THERAPEUTICS SAGE2Cleared 510(K)
- K024023ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER2Cleared 510(K)
- K031983INOVO, INC, ECONOMIZER CONSERVING REGULATOR2Cleared 510(K)
- K032018EASY PULSE II OXYGEN CONSERVER2Cleared 510(K)
- K023673AIRLIFE DEMAND NASAL CANNULA2Cleared 510(K)
- K02286562032Cleared 510(K)
- K023420PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB2Cleared 510(K)
- K020475CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 5112Cleared 510(K)
- K020329DEVILBISS PD10002Cleared 510(K)
- K010747OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-8302Cleared 510(K)
- K010389CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 4112Cleared 510(K)
- K001412PM 1800 CONSERVING DEVICE2Cleared 510(K)
- K003455MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 4012Cleared 510(K)
- K002284VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX2Cleared 510(K)
- K001579IMPULSE SELECT2Cleared 510(K)
- K992935OCD20012Cleared 510(K)
- K000890CHAD THERAPEUTICS OXYMATIC MODEL 4012Cleared 510(K)
- K992659O2N DEMAND-II, VICTOR MODEL OCPR-II2Cleared 510(K)
- K982943TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-30002Cleared 510(K)
- K990678PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)2Cleared 510(K)
- K983601DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC2Cleared 510(K)
- K983459PULSED OXYGEN CONSERVING DEVICE, POCD2Cleared 510(K)
- K964541SANPO I2Cleared 510(K)
- K970371FLOTEC OXYSAVRR (S)2Cleared 510(K)
- K963247VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR2Cleared 510(K)
- K962944TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)2Cleared 510(K)
- K961126PULSE DOSE SERIES2Cleared 510(K)
- K962766AIRSEP IMPULSE2Cleared 510(K)
- K955129OXYPULSE EOC I, EOC II & EOC R2Cleared 510(K)
- K953852MODEL IPD OXYGEN CONSERVING DEVICE2Cleared 510(K)
- K923660MEDISONIC OXYGEN FLOW CONTROLLER2Cleared 510(K)
- K903504HALA'TUS 1 OXYGENATOR2Cleared 510(K)
- K892639THE ORIGINAL PULSE-PAK2Cleared 510(K)
- K892407MODIFIED DEMAND NASAL OXYGEN CANNULA2Cleared 510(K)
- K890141DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)2Cleared 510(K)
- K890298DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/42082Cleared 510(K)
- K884562OXYMATIC-242Cleared 510(K)
- K884754VOYAGER/X2Cleared 510(K)
- K883590OXYTROL2Cleared 510(K)
- K883216BUNN MODEL 50 OXYGEN FLOW CONTROLLER2Cleared 510(K)
- K874804OXYGEN SUPPLY CONTROL REGULATOR (OSCR)2Cleared 510(K)
- K873901COMPANION MINI OXYGEN SAVER2Cleared 510(K)
- K864127MECHANICAL OXYGEN REGULATOR2Cleared 510(K)
- K863695COMPANION OXYGEN SAVER2Cleared 510(K)
- K861325MAXI-USE O2 DEVICE2Cleared 510(K)
- K861199BUNN MODEL 22 OXYGEN FLOW CONTROLLER2Cleared 510(K)
- K853378AUTO PRO2Cleared 510(K)
- K852650OXYMATICTM ELECTRONIC OXGYEN CONSERVER2Cleared 510(K)
- K851235DEMAND OXYGEN SAUER DOS2 MODEL 102Cleared 510(K)
- K834588OXYMIZER-PENDANT2Cleared 510(K)
- K830009OXYMIZER2Cleared 510(K)
- 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
- 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
SANPO I
- Page Type
- Cleared 510(K)
- 510(k) Number
- K964541
- 510(k) Type
- Traditional
- Applicant
- KOIKE MEDICAL CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/26/1997
- Days to Decision
- 329 days
- Submission Type
- Summary