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
- K163277SuperNO2VA Device1Cleared 510(K)
- K953107ANESTHESIA/RESPIRATORY FACE MASK1Cleared 510(K)
- K953295ANESTHESIA FACE MASK1Cleared 510(K)
- K952689BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK1Cleared 510(K)
- K951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK1Cleared 510(K)
- K950771DISPOSABLE ADHESIVE FACE MASK1Cleared 510(K)
- K945894MASK, GAS, ANESTHETIC1Cleared 510(K)
- K945440DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK1Cleared 510(K)
- K944157DISPOSABLE, PREFORMED FACE MASK1Cleared 510(K)
- K932147NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE1Cleared 510(K)
- K932014AMBU DISPOSABLE FACE MASK1Cleared 510(K)
- K915558IAS ANESTHESIA MASK1Cleared 510(K)
- K903881VENTLAB VENT-MASK, CAT# VR 0010/20/301Cleared 510(K)
- K902298ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS1Cleared 510(K)
- K891316ANESTHESIA/RESPIRATORY DISPOSABLE MASK1Cleared 510(K)
- K884157MODIFIED TOUCH-ME-NOT MASK1Cleared 510(K)
- K890795RESPIRONICS SEALEASY II1Cleared 510(K)
- K890108MODIFIED CUSHION-FLEX(TM)1Cleared 510(K)
- K884387CUSHION FLEX(TM)1Cleared 510(K)
- K882434MASK, GAS, ANESTHETIC1Cleared 510(K)
- K881393RONDEX RESCUE MASK1Cleared 510(K)
- K881067NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK1Cleared 510(K)
- K880682MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP1Cleared 510(K)
- K874746SEALFLEX MASK1Cleared 510(K)
- K872015SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)1Cleared 510(K)
- K871851RIBBED CUSHION MASK1Cleared 510(K)
- K862781MP-XMM DISPOSABLE FACE MASK1Cleared 510(K)
- K862784MP-XMO DISPOSABLE FACE MASK1Cleared 510(K)
- K862783MP-XMV DISPOSABLE FACE MASK1Cleared 510(K)
- K862782MP-XML DISPOSABLE FACE MASK1Cleared 510(K)
- K860686FACEGLOV,ANESTHETIC GAS MASK1Cleared 510(K)
- K853785SERIES 2000 MEDS MASK1Cleared 510(K)
- K854161SUR-FIT FACE MASK1Cleared 510(K)
- K850263PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY1Cleared 510(K)
- K844493MEDIPART FACE MASK & FILTER MP-30XM1Cleared 510(K)
- K844494MEDIPART FACE MASK MP-XM1Cleared 510(K)
- K843169CUSHION-FLEX TM1Cleared 510(K)
- K842472DRYDEN INFLATABLE MASK1Cleared 510(K)
- K841240DISPOSABLE ANESTHESIA MASK1Cleared 510(K)
- K840535DISPOS. ANESTHESIA FACE MASK1Cleared 510(K)
- K840452PREMIUM DABM DISPOS. ANES. BREATH MASK1Cleared 510(K)
- K834536CRYSTALCONE FACE MASK-MED-W/HOOKRING1Cleared 510(K)
- K834454PAEDIATRIC FACE MASK 1-3 W/WO RING1Cleared 510(K)
- K831713NON CONDUCTIVE ANESTHESIA FACEMASK1Cleared 510(K)
- K830982MASKS1Cleared 510(K)
- K821045NON CONDUCTIVE PEDIATRIC ANES. FACE1Cleared 510(K)
- K810990OHIO NONCONDUCTIVE RBS TYPE FACE MASK1Cleared 510(K)
- K803185NON-CONDUCTIVE ANESTHESIA FACE MASK1Cleared 510(K)
- K801251NON-CONDUCTIVE, SINGLE USE FACE MASK #551Cleared 510(K)
- K790638ACCUTRON POLLUTION REDUCER1Cleared 510(K)
- K782163THE BLUE MASK1Cleared 510(K)
- 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
- 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
SEALFLEX MASK
- Page Type
- Cleared 510(K)
- 510(k) Number
- K874746
- 510(k) Type
- Traditional
- Applicant
- ENGINEERED MEDICAL SYSTEMS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/21/1987
- Days to Decision
- 33 days