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
- K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)2Cleared 510(K)
- K230931Atlan2Cleared 510(K)
- K213867Carestation 750/750c2Cleared 510(K)
- K201957A8, A9 Anesthesia System2Cleared 510(K)
- K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System2Cleared 510(K)
- K171311A5 Anesthesia System2Cleared 510(K)
- K171292A7 Anesthesia System2Cleared 510(K)
- K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS22Cleared 510(K)
- K170872Aisys CS22Cleared 510(K)
- K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C402Cleared 510(K)
- K151570Carestation 620/650/650C2Cleared 510(K)
- K151954A7 Anesthesia System2Cleared 510(K)
- K143530Aespire View2Cleared 510(K)
- K142552A7 Anesthesia System2Cleared 510(K)
- K140264MADM2Cleared 510(K)
- K132903DRE VENTURA2Cleared 510(K)
- K133886PERSEUS A5002Cleared 510(K)
- K131790A9800 ANESTHESIA WORKSTATION2Cleared 510(K)
- K133958FLOW-I ANESTHESIA SYSTEM C20, C30 & C402Cleared 510(K)
- K132530GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)2Cleared 510(K)
- K131945GE DATEX-OHMEDA AVANCE CS22Cleared 510(K)
- K122063INTELLISAVE AX700 ANESTHESIA SYSTEM2Cleared 510(K)
- K123211A5 ANESTHESIA DELIVERY SYSTEM2Cleared 510(K)
- K123125GE DATEX-OHMEDA AVANCE CS22Cleared 510(K)
- K122445AESPIRE 7900, AESPIRE VIEW2Cleared 510(K)
- K113633MCKESSON ANESTHESIA CARE2Cleared 510(K)
- K103035SMARTPILOT VIEW MODEL MK045002Cleared 510(K)
- K120075AM-6000 ANESTHESIA MACHINE2Cleared 510(K)
- K112114MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C402Cleared 510(K)
- K112722GE DATEX-OHMEDA AVANCE2Cleared 510(K)
- K110213GE DATEX-OHMEDA AISYS2Cleared 510(K)
- K102389NAVIGATOR APPLICATIONS SUITE2Cleared 510(K)
- K102182MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 302Cleared 510(K)
- K102471AS3700 ANESTHSIA DELIVERY SYSTEM2Cleared 510(K)
- K101439CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P2Cleared 510(K)
- K092864AESPIRE 7900, AESPIRE VIEW2Cleared 510(K)
- K090892GE DATEX-OHMEDA S/5 ADU CARESTATION2Cleared 510(K)
- K083098NAVIGATOR APPLICATIONS SUITE2Cleared 510(K)
- K090233GE DATEX-OHMEDA AISYS2Cleared 510(K)
- K083413COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM2Cleared 510(K)
- K081447FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO2Cleared 510(K)
- K081844GE DATEX-OHMEDA AVANCE2Cleared 510(K)
- K081941NAVIGATOR APPLICATIONS SUITE2Cleared 510(K)
- K072884FABIUS MRI2Cleared 510(K)
- K080175NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-012Cleared 510(K)
- K073707GE DATEX-OHMEDA AISYS2Cleared 510(K)
- K072420MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE2Cleared 510(K)
- K071097NAVIGATOR APPLICATIONS SUITE2Cleared 510(K)
- K071142GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM2Cleared 510(K)
- K062388ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM2Cleared 510(K)
- K062155DIGITAL MXR-D FLOWMETER2Cleared 510(K)
- K061102PRIMA ANAESTHESIA MACHINE2Cleared 510(K)
- K061609GE DATEX-OHMEDA AISYS2Cleared 510(K)
- K060193MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 22Cleared 510(K)
- K052335ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA2Cleared 510(K)
- K050883SAFERSLEEP SYSTEM2Cleared 510(K)
- K051629BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 20002Cleared 510(K)
- K050676GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)2Cleared 510(K)
- K050626GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM2Cleared 510(K)
- K050055GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM2Cleared 510(K)
- K042607PRIMUS US2Cleared 510(K)
- K042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM2Cleared 510(K)
- K041430BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 20002Cleared 510(K)
- K033026MALLARD MODEL 3000 ANESTHESIA MACHINE2Cleared 510(K)
- K042154GE DATEX-OHMEDA AISYS CARESTATION2Cleared 510(K)
- K042086FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM2Cleared 510(K)
- K041622MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM2Cleared 510(K)
- K033498NARKOMED 6400, MODEL NM64002Cleared 510(K)
- K040743MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM2Cleared 510(K)
- K030624MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM2Cleared 510(K)
- K032803DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM2Cleared 510(K)
- K031400FABIUS TIRO ANESTHESIA SYSTEM2Cleared 510(K)
- K030939PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE2Cleared 510(K)
- K022031NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-22Cleared 510(K)
- K011404FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS2Cleared 510(K)
- K010613MAGELLAN-2200, MODEL 12Cleared 510(K)
- K012446OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI2Cleared 510(K)
- K003663SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE2Cleared 510(K)
- K003251BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 6902Cleared 510(K)
- K001988MODULAR2Cleared 510(K)
- K003579NARKOMED MRI-2, MODEL NM-MRI-22Cleared 510(K)
- K000995NARKOMAT, MODEL 20002Cleared 510(K)
- K000859OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-12Cleared 510(K)
- K001727MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES2Cleared 510(K)
- K001488NARKOMED MRI , NM-MRI2Cleared 510(K)
- K001315MODIFICATION TO KION ANESTHESIA SYSTEM2Cleared 510(K)
- K000706DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR2Cleared 510(K)
- K993410DATES-OHMEDA AESTIVA SMARTVENT MRI2Cleared 510(K)
- K992421GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 340762Cleared 510(K)
- K973971KION ANESTHESIA SYSTEM2Cleared 510(K)
- K982137BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE2Cleared 510(K)
- K983635JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN2Cleared 510(K)
- K981530SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM2Cleared 510(K)
- K981845HAWK ANAESTHESIA INDUCTION UNIT2Cleared 510(K)
- K973985AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)2Cleared 510(K)
- K980553NARKOMED 6000 MODEL NUMBER NM60002Cleared 510(K)
- K973896OHMEDA EXCEL 3000 ANESTHESIA SYSTEM2Cleared 510(K)
- K973949PERIOPERATIVE DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K974193NARKOMED ULTRASONIC FLOW SENSOR2Cleared 510(K)
- K970163ALPHA MX (20)/ULTRA PC (30)2Cleared 510(K)
- K971030MIE FALCON, DATEX ENGSTROM FLEXIMA II2Cleared 510(K)
- K972848NARKOMED MRI ANESTHESIA SYSTEM2Cleared 510(K)
- K965160HP ORVUE INTRA-OP (M2510A)2Cleared 510(K)
- K971425NARKOMED M ANESTHESIA SYSTEM (M)2Cleared 510(K)
- K963481ANODYNE CC2Cleared 510(K)
- K965041OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM2Cleared 510(K)
- K963994NARKOMED GS ANESTHESIA SYSTEM2Cleared 510(K)
- K946127OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM2Cleared 510(K)
- K945463PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM2Cleared 510(K)
- K945234AS/3 MEMORY MODULE, M0MEM2Cleared 510(K)
- K945722MATRX MDM, RA2Cleared 510(K)
- K933285DATEX AS/3 TM ANAESTHESIA MONITOR2Cleared 510(K)
- K923172ANAESTHESIA RECORD KEEPER2Cleared 510(K)
- K935546MAC/IV SEDATION KIT2Cleared 510(K)
- K934669ARC2Cleared 510(K)
- K930351NARKOMED 2C ANESTHESIA SYSTEM2Cleared 510(K)
- K930492IDACARE ANESTHESIA MANAGEMENT WORKSTATIN2Cleared 510(K)
- K925580OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD2Cleared 510(K)
- K921742OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY2Cleared 510(K)
- K913791OHMEDA 7800 ANESTHESIA VENTILATOR2Cleared 510(K)
- K923519SENSOR GUI2Cleared 510(K)
- K920944FTS-200 GAS SYSTEM2Cleared 510(K)
- K905635OHMEDA MODULUS CD ANESTHESIA SYSTEM2Cleared 510(K)
- K903991PCM ANESTHESIA2Cleared 510(K)
- K903135CLINI-CALC2Cleared 510(K)
- K901117OHMEDA UNIVERSAL PAC2Cleared 510(K)
- K902962LIFELOG(TM)2Cleared 510(K)
- K901713NARKOMED 4 ANESTHESIA SYSTEM2Cleared 510(K)
- K901119OHMEDA MODULUS CD ANESTHESIA SYSTEM2Cleared 510(K)
- K893780OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM2Cleared 510(K)
- K900937O.R. DATA MANAGER2Cleared 510(K)
- K900329NARKOMED 3 ANESTHESIA SYSTEM2Cleared 510(K)
- K900328NARKOMED 2B ANESTHESIA SYSTEM2Cleared 510(K)
- K894309OHMEDA MODULUS CD ANESTHESIA SYSTEM2Cleared 510(K)
- K884802CAVENDISH 460/680 ANESTHESIA MACHINE2Cleared 510(K)
- K884991CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN2Cleared 510(K)
- K890410REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE2Cleared 510(K)
- K884879CENTURION(TM) MIXER2Cleared 510(K)
- K882489REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS2Cleared 510(K)
- K875350OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM2Cleared 510(K)
- K872178MODIFICATION TO ARKIVE(TM)2Cleared 510(K)
- K864589TRI-SERVICE OMV VAPORIZER2Cleared 510(K)
- K864590AM10002Cleared 510(K)
- K864644PHOENIX-C ANESTHESIA MACHINE2Cleared 510(K)
- K864447NARKOMED 2B ANESTHESIA SYSTEM2Cleared 510(K)
- K864806ANESTHESIA RECORDER2Cleared 510(K)
- K862085ARKIVE (TM)2Cleared 510(K)
- K863207OHMEDA 'B' SERIES GAS DELIVERY SYSTEM2Cleared 510(K)
- K862831MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM2Cleared 510(K)
- K861170NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)2Cleared 510(K)
- K855022COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK2Cleared 510(K)
- K853435NARKOMED 3 ANESTHESIA SYSTEM2Cleared 510(K)
- K854213ARI STANDARD ANESTHESIA RECORD2Cleared 510(K)
- K852175PATIENT DATA SYSTEMS CVA2Cleared 510(K)
- K853139PHOENIX ANESTHESIA MACHINE2Cleared 510(K)
- K850648OHMEDA PAC PORTABLE ANESTHESIA SYSTEM2Cleared 510(K)
- K844563PHOENIX ANESTHESIA MACHINE2Cleared 510(K)
- K844849OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA2Cleared 510(K)
- K851621BOOM ARM2Cleared 510(K)
- K844008PENLON AM1000 ANAESTHESIA MACHINE2Cleared 510(K)
- K844421FOREGGER DOME VALVES2Cleared 510(K)
- K844012OHMEDA ANESTHESIA RECORD KEEPER2Cleared 510(K)
- K841370KMA-1300F2Cleared 510(K)
- K840356OHIO UNITROL II ANESTHESIA GAS MACHINE2Cleared 510(K)
- K841274BAG-TO-VENTILATOR SELECTOR VALVE2Cleared 510(K)
- K833147CENTRALERT2Cleared 510(K)
- K833335MODULUS II ANESTHESIA GAS MACHINE2Cleared 510(K)
- K833151BOYLE SYSTEM ANESTHESIA GAS MACHINE2Cleared 510(K)
- K830680AIR-SHIELDS VENTIMETER VENTILATOR-CONTR2Cleared 510(K)
- K830159ANESTHESIA APPARATUS PH-352Cleared 510(K)
- K830161ANESTHESIA APATATUS #D-252Cleared 510(K)
- K830160ANESTHESIA APPARATUS #FO 20S2Cleared 510(K)
- K822218NARKOMED 2A ANESTHESIA MACHINE2Cleared 510(K)
- K803052NUFFIELD ANESTHESIA VENTILATOR SER. 4002Cleared 510(K)
- K802591MODEL 5460 + 5480 POP-OFF VALVES2Cleared 510(K)
- K801102COMPALOR-ORAL SURGERY MODEL2Cleared 510(K)
- K801100ANALOR FOUR-DENTAL MODEL2Cleared 510(K)
- K801103COMPALOR-DENTAL MODEL2Cleared 510(K)
- K800801ANALGESIA UNITS, OXYGEN & NITRATE DEVICE2Cleared 510(K)
- K791530OHIO MODULAR ANESTHESIA GAS MACHINE2Cleared 510(K)
- K790456SERIES 70002Cleared 510(K)
- K781492SERIES 7000 GAS MACHINE2Cleared 510(K)
- K771989CONTINUOUS FLOW ANESTHESIA MACHINE2Cleared 510(K)
- K771479NITROX 30 - ANESTHETIC GAS PROPORTIONER2Cleared 510(K)
- K771057ANESTHESIA MACHINE2Cleared 510(K)
- K770554NARKOMED ANESTHESIA MACHINE2Cleared 510(K)
- K760228ANESTHESIA MACHINE, CHEMETRON2Cleared 510(K)
- 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
- 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
MODULAR
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K001988
- 510(k) Type
- Traditional
- Applicant
- Heyer America, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/5/2001
- Days to Decision
- 221 days
- Submission Type
- Summary