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
- K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber2Cleared 510(K)
- K220290Revitalair 430+2Cleared 510(K)
- K171899Revitalair 430F2Cleared 510(K)
- K163109OxyHeal 4000 Multiplace Hyperbaric Chamber Family2Cleared 510(K)
- K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System2Cleared 510(K)
- K140559SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER2Cleared 510(K)
- K102831RSI 42002Cleared 510(K)
- K092991O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)2Cleared 510(K)
- K101262FLEXI-LITE2Cleared 510(K)
- K100268SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER2Cleared 510(K)
- K082455RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K081506HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS2Cleared 510(K)
- K072427SIGMA SERIES HYPERBARIC CHAMBER2Cleared 510(K)
- K072757DIVE AND SHALLOW AND GRAND DIVE2Cleared 510(K)
- K060739MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-3072Cleared 510(K)
- K053498HYPEROX 1012Cleared 510(K)
- K052866OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K051759FLEXI-LITE, MODEL FL-V1.22Cleared 510(K)
- K052713MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER2Cleared 510(K)
- K040145ATA HCM MONOPLACE HYPERBARIC SYSTEM2Cleared 510(K)
- K041007MILLENIUM, MODELS 2000, 2001 AND 20022Cleared 510(K)
- K030418MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM2Cleared 510(K)
- K030713BAY AREA HYPERSCIENCES2Cleared 510(K)
- K031649SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES2Cleared 510(K)
- K022214MSI I2010 DUAL PLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K021689PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+22Cleared 510(K)
- K021693PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S12Cleared 510(K)
- K021690PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+12Cleared 510(K)
- K020974BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K011592OXYGEN TREATMENT HOOD2Cleared 510(K)
- K011866OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES2Cleared 510(K)
- K001121OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)2Cleared 510(K)
- K011565INFANT OXYGEN TREATMENT HOOD2Cleared 510(K)
- K011312BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM2Cleared 510(K)
- K010659SEA-LONG MEDICAL TREATMENT HOOD2Cleared 510(K)
- K002794MODEL 5000 MULTIPLACE HYPERBARIC THERAPY2Cleared 510(K)
- K002795MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS2Cleared 510(K)
- K001409GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER2Cleared 510(K)
- K993010BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K990927SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K984313HTU32Cleared 510(K)
- K981938TAMPA HYPERBARIC MONOPLACE CHAMBER2Cleared 510(K)
- K983648SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM2Cleared 510(K)
- K972908SANDS SERIES III HYPERBARIC CHAMBER2Cleared 510(K)
- K974868SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K952545WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM2Cleared 510(K)
- K960389HYPERBARIC CHAMBER2Cleared 510(K)
- K962869GSP1 - GAS SELECTION PANEL2Cleared 510(K)
- K962871ODS1 - HOOD DRIVER2Cleared 510(K)
- K955535LOUISVILLE LABS OXYGEN HEAD TENT2Cleared 510(K)
- K951044SYSTEM ONE HYPERBARIC CHAMBER2Cleared 510(K)
- K954387T CLASS HYPERBARIC FACILITIES2Cleared 510(K)
- K950386MODEL 3200P/3200PR HYPERBARIC CHAMBER2Cleared 510(K)
- K934164MODEL 2500E/2500ER HYPERBARIC CHAMBER2Cleared 510(K)
- K951125LIFEFORCE CLINICAL HYPERBARIC FACILITY2Cleared 510(K)
- K950957MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM2Cleared 510(K)
- K933929LAB-SITE(R) SAFETY CANNULA2Cleared 510(K)
- K930748SIGMA MP MULTIPLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K905168HYPERLITE2Cleared 510(K)
- K874752GAMOW HYPERBARIC BAG2Cleared 510(K)
- K874107H.T.U. (HYPERBARIC THERAPY UNIT)2Cleared 510(K)
- K862198SIGMA II - DUAL PLACE HYPERBARIC CHAMBER2Cleared 510(K)
- K861315HYPERBARIC PENETRATION EXTENSION SET2Cleared 510(K)
- K850563SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION2Cleared 510(K)
- K842303MICROSPAN -PH MONITOR2Cleared 510(K)
- K840841RENEAU UNIT2Cleared 510(K)
- K841608MODEL 3000 HYPERBARIC CHAMBER2Cleared 510(K)
- K832127NAUTILUS MONOPLACE HYPERBARIC UNIT2Cleared 510(K)
- K790693HYPERBARIC OXYGEN CHAMBER2Cleared 510(K)
- 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
- 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
LOUISVILLE LABS OXYGEN HEAD TENT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K955535
- 510(k) Type
- Traditional
- Applicant
- LOUISVILLE LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/1/1996
- Days to Decision
- 209 days
- Submission Type
- Statement