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
- 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
- K972397EZ SPRAY1Cleared 510(K)
- K964956E-Z SPACER MASK (SMALL)1Cleared 510(K)
- K961894MDI TUTOR1Cleared 510(K)
- K961455MEDSHIELD/AEROCHAMBER1Cleared 510(K)
- K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-1001Cleared 510(K)
- K922033SALINE SOLUTION- STERILE1Cleared 510(K)
- K900576MODIFIED AEROCHAMBER WITH MASK1Cleared 510(K)
- K900557MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER1Cleared 510(K)
- K895115FRANK INHALER THERMAL S1Cleared 510(K)
- K894215EVOLUTION ULTRASONIC1Cleared 510(K)
- K894555PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED1Cleared 510(K)
- K896070PFEIFFER METERED DOSAGE SYSTEM1Cleared 510(K)
- K895592FREEWAY NEBULIZER COMPRESSOR1Cleared 510(K)
- K894441DEVILBISS MODEL 6610D1Cleared 510(K)
- K894244DEVILBISS MODEL 8500D AND 8500D-6081Cleared 510(K)
- K892117GENTLEHALER(R)1Cleared 510(K)
- K875024DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP1Cleared 510(K)
- K875011DEY-PAK PURIFIED WATER, USP, STERILE1Cleared 510(K)
- K874513MONAGHAN AEROCHAMBER WITH MASK1Cleared 510(K)
- K873793INSPIREASE(R), DRUG DELIVERY SYSTEM1Cleared 510(K)
- K873477INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)1Cleared 510(K)
- K872315MISTMASTER1Cleared 510(K)
- K871151THE SPIRA ELEKTRO 21Cleared 510(K)
- K870332PREFILLED RESPIRATORY THERAPY VIALS1Cleared 510(K)
- K870755CHALLENGER DOSIMETER1Cleared 510(K)
- K870027HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER1Cleared 510(K)
- K860800ROSENTHAL-FRENCH NEBULIZATION DOSIMETER1Cleared 510(K)
- K860875CIRRUS DRUG NEBULIZER MK III1Cleared 510(K)
- K854952CIRRUS NEBULIZER-DELUXE KIT1Cleared 510(K)
- K854551MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S1Cleared 510(K)
- K854550MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA1Cleared 510(K)
- K854520PULMO-AIDE MODEL 5610D1Cleared 510(K)
- K852627MAXI-NEB1Cleared 510(K)
- K853350SYNCHRONER TM (PROPOSED TRADENAME)1Cleared 510(K)
- K853071MEDIX ELECTRONIC NEBULIZING SYSTEM1Cleared 510(K)
- K851525PFEIFFER PUMP1Cleared 510(K)
- K851254MICRO-INHALER MODEL TV-7000 & TV-80001Cleared 510(K)
- K850926MICRON ONE PORTA. ULTRASONIC NEBULIZER1Cleared 510(K)
- K844591MIST-EASE NEBULIZER1Cleared 510(K)
- K843102AVA-NEB NEBULIZER1Cleared 510(K)
- K842988VMT GENTLE-HALER1Cleared 510(K)
- K841991ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS1Cleared 510(K)
- K841988ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT1Cleared 510(K)
- K841989ARM-A-VIAL LV SODIUM CHLORIDE INHALAT1Cleared 510(K)
- K841990ARM-A-CARE NEBULIZER-NEBULIZER1Cleared 510(K)
- K841987ARM-A-VIAL LV STERIAL WATER FOR INHALA1Cleared 510(K)
- K842192CROUP TENT FRAME1Cleared 510(K)
- K841894VMT HAND HELD NEBULIZER1Cleared 510(K)
- K841469MISTY OX DISPOS. NEBULIZER1Cleared 510(K)
- K841321AIR-NEB NEBULIZER COMPRESSOR UNIT1Cleared 510(K)
- K833474VIRALIZER NEBULIZER SPRAYER1Cleared 510(K)
- K832037INSPIREASE1Cleared 510(K)
- K823423NEBULIZER CHRONOLOG & INTERPRETER1Cleared 510(K)
- K822625SYNTEVENT ATOMIZER/NEBULIZER AEROSOL1Cleared 510(K)
- K812503BOSCH HEARING INSTRUMENTS1Cleared 510(K)
- K811404TRAVELAIRE1Cleared 510(K)
- K810343NEBULIZERS1Cleared 510(K)
- K802281SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC1Cleared 510(K)
- K800763MISER INHALATION DEVICE, PART NO. 7001Cleared 510(K)
- K781394DISPOSABLE INCENTIVE SPIROMETER1Cleared 510(K)
- K781073PULMO-SONIC1Cleared 510(K)
- K760580DRUG NEBULIZER1Cleared 510(K)
- 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
DEY-PAK PURIFIED WATER, USP, STERILE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K875011
- 510(k) Type
- Traditional
- Applicant
- DEY LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/22/1988
- Days to Decision
- 49 days