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BTI — Compressor, Air, Portable Class II

FDA Device Classification

FDA product code BTI covers "Compressor, Air, Portable", a Class II medical device regulated under 21 CFR 868.6250. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
BTI
Device Class
Class II
Regulation Number
868.6250
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K131881trudell medical intlOMBRA TABLE TOP COMPRESSOROctober 24, 2013
K113338oricareMEDICAL AIR COMPRESSORAugust 10, 2012
K091871ekom s.r.oDK50 DSOctober 23, 2009
K072634emg technology coEMG TRITON -COMP,MODEL NCA01-XXX SERIESNovember 19, 2008
K060781ekom s.r.oMEDICAL COMPRESSOR, MODELS DK50 D AND DMOctober 3, 2006
K051691precision medicalMINIMATE COMPRESSORDecember 9, 2005
K041781hamilton medicalVENTILAIR II MEDICAL AIR COMPRESSORMarch 14, 2005
K041406newport medical instrumentsNEWPORT C250 AIR COMPRESSOR MODEL C250December 15, 2004
K041974med2000MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZERAugust 24, 2004
K040220event medicalMEDICAL AIR COMPRESSORJune 9, 2004
K031686medline industriesAEROMIST LT, MODEL HCS15004January 21, 2004
K031413vega technologiesVIGORMIST COMPRESSOR NEBULIZEROctober 7, 2003
K023354siemens elemaCOMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81ESeptember 5, 2003
K020797nidek medical productsPULMO-MIST COMPRESSOR MODEL # 4323May 3, 2002
K013027respironics healthscanMISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123December 6, 2001
K002862pari holdingPRONEB ULTRA MODEL NUMBER 85B0100March 13, 2001
K002468san upSAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050March 2, 2001
K982789dragerMEDICAL AIR COMPRESSOR, MODEL # 8413419October 29, 1998
K963349devilbiss health careDEVILBISS 8650DJune 13, 1997
K951926allan rehnstromALRECO 40400December 8, 1995

FDA data resources