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
- Subpart G—MiscellaneousCFR Sub-Part
- BRXStool, Anesthesia1Product Code
- BRYCabinet, Table And Tray, Anesthesia1Product Code
- BSYCatheters, Suction, Tracheobronchial1Product Code
- BTICompressor, Air, Portable2Product Code
- K131881OMBRA TABLE TOP COMPRESSOR2Cleared 510(K)
- K113338MEDICAL AIR COMPRESSOR2Cleared 510(K)
- K091871DK50 DS2Cleared 510(K)
- K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIES2Cleared 510(K)
- K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DM2Cleared 510(K)
- K051691MINIMATE COMPRESSOR2Cleared 510(K)
- K041781VENTILAIR II MEDICAL AIR COMPRESSOR2Cleared 510(K)
- K041406NEWPORT C250 AIR COMPRESSOR MODEL C2502Cleared 510(K)
- K041974MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER2Cleared 510(K)
- K040220MEDICAL AIR COMPRESSOR2Cleared 510(K)
- K031686AEROMIST LT, MODEL HCS150042Cleared 510(K)
- K031413VIGORMIST COMPRESSOR NEBULIZER2Cleared 510(K)
- K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E2Cleared 510(K)
- K020797PULMO-MIST COMPRESSOR MODEL # 43232Cleared 510(K)
- K013027MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS1232Cleared 510(K)
- K002862PRONEB ULTRA MODEL NUMBER 85B01002Cleared 510(K)
- K002468SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 30502Cleared 510(K)
- K982789MEDICAL AIR COMPRESSOR, MODEL # 84134192Cleared 510(K)
- K963349DEVILBISS 8650D2Cleared 510(K)
- K951926ALRECO 404002Cleared 510(K)
- K945478AM-50 AEROSOL/MEDICATION AIR COMPRESSOR2Cleared 510(K)
- K952616MICROTIME2Cleared 510(K)
- K946039MODEL #5000 PULMO PLUS2Cleared 510(K)
- K940630503 MAXI COMPRESSOR2Cleared 510(K)
- K930509PM PUMP COMPRESSOR2Cleared 510(K)
- K925010NEBULIZER PUMP, POWERED, MODEL 11102Cleared 510(K)
- K925011NEBULIZER PUMP, POWERED MODEL 11802Cleared 510(K)
- K931015DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER2Cleared 510(K)
- K913097SAM ST2Cleared 510(K)
- K922623NEBULIZER SYSTEM2Cleared 510(K)
- K920954AIR STAR2Cleared 510(K)
- K902520AIR PLUS NEBULIZER2Cleared 510(K)
- K904045#504 MINI COMPRESSOR2Cleared 510(K)
- K902184MAXI ASPIRATOR2Cleared 510(K)
- K902762PM14 SOFT AIR COMPRESSOR2Cleared 510(K)
- K900686MAXI COMPRESSORS2Cleared 510(K)
- K894831PORTABLE AIR COMPRESSOR MODEL NUMBER 81252Cleared 510(K)
- K883829TURBO AIR COMPRESSOR 80002Cleared 510(K)
- K884722LUMINEB I2Cleared 510(K)
- K883704MULTIICHALLENGE NEBULIZER SYSTEM2Cleared 510(K)
- K883132NEBULIZER PUMP POWERED MODELS 020 AND 0502Cleared 510(K)
- K873677ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER2Cleared 510(K)
- K871829SIEMENS DRY AIR COMPRESSOR2Cleared 510(K)
- K870428AEROSOL ONE, NEBULIZER PUMP2Cleared 510(K)
- K864547BIRD 6500 AIR COMPRESSOR2Cleared 510(K)
- K864680MOBIL 022Cleared 510(K)
- K863339DURA NEB(TM) 2000 PORTABLE COMPRESSOR2Cleared 510(K)
- K862628BUNN MODEL 510 MEDICATION COMPRESSOR2Cleared 510(K)
- K861865ERIE-NEB2Cleared 510(K)
- K852622AEROSOL ONE2Cleared 510(K)
- K854747TRAVONEB MODEL # TONE 12Cleared 510(K)
- K853944CPAP BLOWER2Cleared 510(K)
- K854306OHMEDA CPU AIR COMPRESSOR MODEL 33502Cleared 510(K)
- K850795AIR COMPRESSOR2Cleared 510(K)
- K844956AVA-MIST PORTABLE AIR COMPRESSOR2Cleared 510(K)
- K841537IMPACT MODEL 6012Cleared 510(K)
- K833501MEDI-MIST PORTA. COMPRESSOR DRIVEN2Cleared 510(K)
- K832220TRAVELER NEBULIZING SYSTEM2Cleared 510(K)
- K832072VITA-MIST AIR COMPRESSOR & NEBULIZER2Cleared 510(K)
- K830417RESPI-NEB-AEROSOL SYSTEM2Cleared 510(K)
- K822685NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY2Cleared 510(K)
- K822512REPCO EASY-BREATHER CLINICAL AIR PUMP2Cleared 510(K)
- K820079AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL2Cleared 510(K)
- K813311COMPRESSOR, AIR, PORTABLE2Cleared 510(K)
- K812766PCS-5 ACCESSORIES2Cleared 510(K)
- K812767SNIFF AIR COMPRESSOR #SF-62Cleared 510(K)
- K802253AIR COMPRESSOR ADAPTOR KIT2Cleared 510(K)
- K801286PORTA-NEB(R) 3102Cleared 510(K)
- K800534MODEL 52 BUNN DRY AIR SUPPLY2Cleared 510(K)
- K792457COMPRESSOR2Cleared 510(K)
- K790912ARIDYNE 35002Cleared 510(K)
- K781213COMPRESSOR, AIR, MINI-SILENT2Cleared 510(K)
- K771707ADIDYNE 30002Cleared 510(K)
- K761294RESPIRATORY BLOWER2Cleared 510(K)
- BXJClip, Nose1Product Code
- BXKGas, Calibration (Specified Concentration)1Product Code
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)1Product Code
- CAMYoke Assembly, Medical Gas1Product Code
- CCXSupport, Patient Position1Product Code
- OFOAirway Suction Kit1Product Code
- OFRTracheobronchial Suction Catheter Kit1Product Code
- OFSTracheal Suction Set1Product Code
- OYINon-Bronchoscopic Bronchoalveolar Lavage Catheter1Product Code
- 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
MODEL #5000 PULMO PLUS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K946039
- 510(k) Type
- Traditional
- Applicant
- INTERNATIONAL MEDICAL SYSTEMS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/16/1995
- Days to Decision
- 186 days
- Submission Type
- Summary