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
- K955008HEAT & MOISTURE EXCHANGER1Cleared 510(K)
- K954194DISPOSABLE HME/FILTER1Cleared 510(K)
- K953580HEAT MOISTURE EXCHANGER1Cleared 510(K)
- K953507TYPE 1 & 2 (HUMIDAIR I & II)1Cleared 510(K)
- K953620WARM N WET HMEF W/LUER ADAPTER1Cleared 510(K)
- K953619WARM N WET HME W/LUER ADAPTER1Cleared 510(K)
- K953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT1Cleared 510(K)
- K953540EEE1Cleared 510(K)
- K953491HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE1Cleared 510(K)
- K952845HUMID-VENT TRACH-VENT1Cleared 510(K)
- K952844HUMID-VENT 21Cleared 510(K)
- K952750HUMID-VENT 11Cleared 510(K)
- K952823FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE1Cleared 510(K)
- K952084HUMID-VENT FILTER PEDI1Cleared 510(K)
- K952036FLEXLIFE1Cleared 510(K)
- K946209DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME1Cleared 510(K)
- K951856HUMID-VENT MICRO1Cleared 510(K)
- K950447FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT1Cleared 510(K)
- K945359AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H1Cleared 510(K)
- K945657DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER1Cleared 510(K)
- K943915HEAT AND MOISTURE EXCHANGER FILTER (HME)1Cleared 510(K)
- K944194DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME1Cleared 510(K)
- K942794HYGROLIFE1Cleared 510(K)
- K941987HEAT AND MOISTURE EXCHANGERS AND FILTERS1Cleared 510(K)
- K941436AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF1Cleared 510(K)
- K941813VENSHIELD1Cleared 510(K)
- K941585HYGROSTER1Cleared 510(K)
- K941535TRACHEOLIFE1Cleared 510(K)
- K935036HEPA FILTERED HEAT AND MOISTURE EXCHANGER1Cleared 510(K)
- K934441KING SYSTEMS HME1Cleared 510(K)
- K934190HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION1Cleared 510(K)
- K933597AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH1Cleared 510(K)
- K925622FHB, FHB-T, FHBFLEX, FHBFLEX-T1Cleared 510(K)
- K922946VAPORTEMP HEAT AND MOISTURE EXCHANGER1Cleared 510(K)
- K9238655701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID1Cleared 510(K)
- K923910HEAT MOISTURE CONDENSER1Cleared 510(K)
- K915786BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.1Cleared 510(K)
- K914336BREATHE EASY1Cleared 510(K)
- K912700FLOCARE DRY CAS SAMPLING PORT MODELS1Cleared 510(K)
- K912699FLOCARE LF-A1Cleared 510(K)
- K912333ARTEMA AQUA+1Cleared 510(K)
- K912336ARTEMA AQUA+ FLEX1Cleared 510(K)
- K912335ARTEMA AQUA+ N1Cleared 510(K)
- K912334ARTEMA AQUA+ T & TS1Cleared 510(K)
- K903519INTERTECH(TM) HEAT AND MOISTURE EXCHANGER1Cleared 510(K)
- K904338ICOR HCH 4, ICOR HCH 71Cleared 510(K)
- K904193FLOCARE1Cleared 510(K)
- K903057FREEVENT (TM)1Cleared 510(K)
- K903058BACT-HME (TM)1Cleared 510(K)
- K903054HME-10 (TM)1Cleared 510(K)
- K902501FLOCARE N1Cleared 510(K)
- K900150HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE1Cleared 510(K)
- K885313HUMIDI-FLEX TM1Cleared 510(K)
- K893875FLOCARE1Cleared 510(K)
- K881657HUMID-VENT FILTER1Cleared 510(K)
- K881656HUMID-VENT 2 S FLEX1Cleared 510(K)
- K881644HUMID-VENT 2 S1Cleared 510(K)
- K881308BREATH-EASY1Cleared 510(K)
- K874597THERMOVENT 600, 1200, T, 021Cleared 510(K)
- K873768HUMID-VENT(R) 2 PORT1Cleared 510(K)
- K873767HUMID-VENT(R) MINI1Cleared 510(K)
- K872371ICOR NEONATAL HCH1Cleared 510(K)
- K872153STOM-VENT1Cleared 510(K)
- K864095ENGSTROM EDITH MODELS 500,1000,1500 & 1500F1Cleared 510(K)
- K862020HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER1Cleared 510(K)
- K854012AMERICAN PHARMASEAL HUMIDAIR CONDENSER1Cleared 510(K)
- K852601SERVO HUMIDIFIER 1531Cleared 510(K)
- K844040SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB1Cleared 510(K)
- K834292PALL HEAT MOISTURE EXCHANGING FILTER1Cleared 510(K)
- K840398INLINE FOAM NOSE1Cleared 510(K)
- K840399FOAM NOSE1Cleared 510(K)
- K821365ENGSTOM EDITH1Cleared 510(K)
- K790681SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 1501Cleared 510(K)
- 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
- 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
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K864095
- 510(k) Type
- Traditional
- Applicant
- GAMBRO, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/20/1987
- Days to Decision
- 122 days