Anesthesiology
Review Panel
- 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
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EAGCephalometer2Product Code
- EAHCone, Radiographic, Lead-Lined1Product Code
- EAPUnit, X-Ray, Intraoral2Product Code
- EHBCollimator, X-Ray1Product Code
- EHDUnit, X-Ray, Extraoral With Timer2Product Code
- MUHSystem, X-Ray, Extraoral Source, Digital2Product Code
- EAMScreen, Intensifying, Radiographic1Product Code
- EGTController, Temperature, Radiographic2Product Code
- EGWDryer, Film, Radiographic2Product Code
- EGYProcessor, Radiographic-Film, Automatic, Dental2Product Code
- HBKChair, Pneumoencephalographic2Product Code
- ITXTransducer, Ultrasonic, Diagnostic2Product Code
- ITYAssembly, Tube Housing, X-Ray, Diagnostic1Product Code
- IWNCassette, Measurement, Ardran-Crooks1Product Code
- IWYHolder, Head, Radiographic1Product Code
- IWZFilm, Radiographic1Product Code
- IXACassette, Radiographic Film2Product Code
- IXCIlluminator, Radiographic-Film1Product Code
- IXDSource, Calibration, Sealed, Nuclear1Product Code
- IXFTest-Pattern, Radiographic1Product Code
- IXGPhantom, Anthropomorphic, Radiographic1Product Code
- IXHCamera, Focal Spot, Radiographic1Product Code
- IXJGrid, Radiographic1Product Code
- IXKSystem, Imaging, X-Ray, Electrostatic2Product Code
- IXLDevice, Spot-Film2Product Code
- IXOSynchronizer, Ecg / Respirator, Radiographic1Product Code
- IXQTable, Radiographic, Stationary Top2Product Code
- IXRTable, Radiographic, Tilting2Product Code
- IXWProcessor, Radiographic-Film, Automatic2Product Code
- IXXProcessor, Cine Film2Product Code
- IXYHolder, Radiographic Cassette, Wall-Mounted1Product Code
- IYBTube Mount, X-Ray, Diagnostic1Product Code
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2Product Code
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- K200916Patient Administration Set2Cleared 510(K)
- K953513XENON CIRCUIT2Cleared 510(K)
- K952223XENON GAS BREATHING CIRCUIT2Cleared 510(K)
- K914747XENON CIRCUIT2Cleared 510(K)
- K913416TETLEY PATIENT ADMINISTRATION SET2Cleared 510(K)
- K912626BOLUS XENON CIRCUIT2Cleared 510(K)
- K903805AMICI XENON ADMINISTRATION SET2Cleared 510(K)
- K904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION2Cleared 510(K)
- K903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE2Cleared 510(K)
- K896885DISPOSABLE RESPIRTORY KIT (MP-200)2Cleared 510(K)
- K896125MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M2Cleared 510(K)
- K896476DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD2Cleared 510(K)
- K896475DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD2Cleared 510(K)
- K896124MEDIPART DISPOSABLE XENON-133 REBREATHING MP-01332Cleared 510(K)
- K881812AERO-MIST NEBULIZER2Cleared 510(K)
- K871868VENTI-SCAN II2Cleared 510(K)
- K872920AMICI KRYPTON ADMINISTRATION SYSTEM*2Cleared 510(K)
- K865107AERO-VENT AEROSOL UNIT2Cleared 510(K)
- K865084AMICI XENON REBREATHING SYSTEM*2Cleared 510(K)
- K865027IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C2Cleared 510(K)
- K863996MODEL XE-103 XENON/MASTER II2Cleared 510(K)
- K863778VENTICIS II2Cleared 510(K)
- K862794MP-070 RADIOAEROSOL KIT2Cleared 510(K)
- K862791MP-30XM-IE FACE MASK AND FILTER KIT2Cleared 510(K)
- K862792MP-066 RADIOAEROSOL KIT2Cleared 510(K)
- K862793MP-066-M RADIOAEROSOL KIT2Cleared 510(K)
- K862795MP-070-M RADIOAEROSOL KIT2Cleared 510(K)
- K853576MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M2Cleared 510(K)
- K853579MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-01332Cleared 510(K)
- K853570MEDIPART DRIERITE MP-10022Cleared 510(K)
- K851201MEDIPART LUND AEROSOL KIT MP-1024A-M2Cleared 510(K)
- K851198MEDIPART LUNG AEROSOL KIT MP-1012A2Cleared 510(K)
- K851199MEDIPART LUNG AEROSOL KIT MP-1012A-M2Cleared 510(K)
- K851200MEDIPART LUNG AEROSOL KIT MP-1024A2Cleared 510(K)
- K850836MEDIPART FACE MASK MP-XM-I2Cleared 510(K)
- K850837MEDIPART FACE MASK & FILTER MP-30XM-I2Cleared 510(K)
- K853056RESPIR GARD-II FACE MASK CORRUGATED TUBING2Cleared 510(K)
- K852693XEN-REX I2Cleared 510(K)
- K850366MEDIPART XENON BREATHING KIT MP-OIXM-I2Cleared 510(K)
- K850367MEDIPART XENON BREATHING KIT MP-02XM-I2Cleared 510(K)
- K843640XENON XE 127/XE 133 GAS DISPENSER2Cleared 510(K)
- K844496MEDIPART XENON BREATHING KIT MP-01XM2Cleared 510(K)
- K844495MEDIPART XENON BREATHING KIT MP-02XM2Cleared 510(K)
- K820571XENAMATIC SERIES OF XENON REBREATH DEV2Cleared 510(K)
- K820143XENON DELIVERY SYSTEM2Cleared 510(K)
- K811118KRYPTON MASKS & TUBING2Cleared 510(K)
- K810819MEDI/NUCLEAR #XE-102 XENON/MASTER2Cleared 510(K)
- K781933DISPENSOR, XENON GAS2Cleared 510(K)
- K781107DISPENSER, GAS XENON2Cleared 510(K)
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2Product Code
- MUABone Sonometer2Product Code
- MUEFull Field Digital, System, X-Ray, Mammographic2Product Code
- MUIMedia, Coupling, Ultrasound2Product Code
- MWPCabinet, X-Ray System2Product Code
- MYNAnalyzer, Medical Image2Product Code
- NCSSystem, Imaging, Holography, Acoustic2Product Code
- NWEColon Computed Tomography System, Computer Aided Detection2Product Code
- OASX-Ray, Tomography, Computed, Dental2Product Code
- OEBLung Computed Tomography System, Computer-Aided Detection2Product Code
- OIIArthrogram Tray2Product Code
- OIJBiopsy Needle Guide Kit2Product Code
- OIKRadiology Dental Tray2Product Code
- OILDiscography Kit2Product Code
- OIMMri Disposable Kit2Product Code
- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
- OQQDiagnostic Ultrasonic Transducer, Robotic2Product Code
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2Product Code
- OWBInterventional Fluoroscopic X-Ray System2Product Code
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2Product Code
- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2Product Code
- QFMRadiological Computer-Assisted Prioritization Software For Lesions2Product Code
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2Product Code
- QHXFluoroscopic X-Ray Image Intensifier1Product Code
- QHYSolid State Fluoroscopic X-Ray Imager2Product Code
- QIHAutomated Radiological Image Processing Software2Product Code
- QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence2Product Code
- QKBRadiological Image Processing Software For Radiation Therapy2Product Code
- RCCC-Arm Fluoroscopic X-Ray System2Product Code
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2Product Code
- QXLCabinet, Emission Computed Tomography System2Product Code
- SFVX-Ray, Computed Tomography, Cone-Beam2Product Code
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
XENAMATIC SERIES OF XENON REBREATH DEV
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K820571
- 510(k) Type
- Traditional
- Applicant
- DIVERSIFIED P.A.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/31/1982
- Days to Decision
- 29 days