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
- 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
- K172702Tec 820, Tec 8502Cleared 510(K)
- K150167V60 Anesthetic Vaporizer2Cleared 510(K)
- K110608SEVOFLURANE VAPORIZER ADAPTOR2Cleared 510(K)
- K060331SIGMA ALPHA VAPORIZER2Cleared 510(K)
- K053564KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 534542Cleared 510(K)
- K051666GAV - GENERAL ANAESTHETIC VAPORIZER2Cleared 510(K)
- K042276D-VAPOR2Cleared 510(K)
- K041076DELTA T2Cleared 510(K)
- K031027DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)2Cleared 510(K)
- K012924DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER2Cleared 510(K)
- K002343SIGMA DELTA2Cleared 510(K)
- K002878DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER2Cleared 510(K)
- K000275DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA2Cleared 510(K)
- K990132DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC2Cleared 510(K)
- K980489VAPAMASTA 62Cleared 510(K)
- K980884SIEMENS SEVOFLURANE VAPORIZER SV 9532Cleared 510(K)
- K981773DRAGER-VAPOR 19.32Cleared 510(K)
- K981472DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS2Cleared 510(K)
- K973051DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS2Cleared 510(K)
- K971923DRAGER-VAPOR 20002Cleared 510(K)
- K952083TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE2Cleared 510(K)
- K961468QUIK-FIL VAPORIZER KEYED FILLER2Cleared 510(K)
- K960944PPV VAPORIZER (MODIFICATION)2Cleared 510(K)
- K954801TECHFIL2Cleared 510(K)
- K953748TECHNOFIL2Cleared 510(K)
- K942799DATUM2Cleared 510(K)
- K942091OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE2Cleared 510(K)
- K945993VAPOFIL2Cleared 510(K)
- K942545SIGMA ELITE2Cleared 510(K)
- K942055DRAGER-VAPOR 19.12Cleared 510(K)
- K936046SIGMA ELITE2Cleared 510(K)
- K923265FUNNEL ADAPTOR2Cleared 510(K)
- K913593OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER2Cleared 510(K)
- K892057OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER2Cleared 510(K)
- K884686VAPAMASTA 52Cleared 510(K)
- K884090LUNDY VAPORIZER SYSTEM2Cleared 510(K)
- K882500VAPORIZER, ANESTHESIA, NON-HEATED2Cleared 510(K)
- K872053KEYFILL2Cleared 510(K)
- K864605VAPLOK2Cleared 510(K)
- K861839VAPOFIL2Cleared 510(K)
- K860545VAPORIZER SPACER2Cleared 510(K)
- K854202ANESTHESIA VENTILATOR MODEL 1002Cleared 510(K)
- K844007PENLON PPV VAPORIZER2Cleared 510(K)
- K843993ANAESLOCK THREE VAPORIZER INTERLOCK HVA0032Cleared 510(K)
- K841157HALOTHANE VAPORIZER 950, ENFLURANE2Cleared 510(K)
- K831427CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.2Cleared 510(K)
- K821966MODULUS VERNI-TROL ANESTHETIC VAPORIZER2Cleared 510(K)
- K821650DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS2Cleared 510(K)
- K810289MODULUS VERNI-TROL ANESTHETIC VAPORIZER2Cleared 510(K)
- K790359HALOTHANE VAPORIZER 950, & ENFLURANE 9512Cleared 510(K)
- K771892VALVE ANESTHETIC2Cleared 510(K)
- K771899VAPOR 192Cleared 510(K)
- K771150COPPER KETTLE VAPORIZER PLUS2Cleared 510(K)
- K770021MASK, FACE, SURGICAL2Cleared 510(K)
- K761160MODEL CNA-1 VAPORIZER2Cleared 510(K)
- K760668SELECTATEC SYSTEM2Cleared 510(K)
- 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
SIGMA ELITE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K936046
- 510(k) Type
- Traditional
- Applicant
- PENLON, INC.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/4/1994
- Days to Decision
- 319 days
- Submission Type
- Summary