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510(k) K940630

503 MAXI COMPRESSOR by Medical Industries America, Inc. — Product Code BTI

K940630 is an FDA 510(k) premarket notification submitted by Medical Industries America, Inc. for the device "503 MAXI COMPRESSOR". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Medical Industries America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
February 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

Other clearances by Medical Industries America, Inc.

  • K050990 — REMREST HEATED HUMIDIFIER (May 2, 2005)
  • K032170 — TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 (May 28, 2004)
  • K002763 — REMREST (May 4, 2001)
  • K011053 — OPTIMA (April 20, 2001)
  • K964078 — 3050 SPORT-NEB (January 10, 1997)
  • K943990 — 3000 AEROSOL TWO (March 21, 1995)
  • K942444 — 3002 AEROMAX (March 10, 1995)
  • K941961 — 605 VACU-MAX (March 2, 1995)
  • K942208 — 4003 AEROLITE (February 24, 1995)
  • K905593 — SLEEPAP (April 23, 1991)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources