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510(k) K051691

MINIMATE COMPRESSOR by Precision Medical, Inc. — Product Code BTI

K051691 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "MINIMATE COMPRESSOR". The FDA issued a decision of Substantially Equivalent on December 9, 2005. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2005
Date Received
June 23, 2005
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 Precision Medical, Inc.

  • K173807 — Accu O2 Oxygen Analyzer (May 2, 2018)
  • K140179 — EASY GO VAC (April 25, 2014)
  • K103563 — PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 (July 1, 2011)
  • K103324 — PRECISION LIQUID OXYGEN SYSTEM (April 21, 2011)
  • K090781 — HELIO2 BLENDER (August 13, 2009)
  • K072348 — PRECISION OXYGEN CONCENTRATOR (October 27, 2008)
  • K063096 — PRECISION OXYGEN MONITOR (February 27, 2007)
  • K053232 — PRECISION BLENDER (January 10, 2006)
  • K041122 — PRECISION LIQUID OXYGEN SYSTEM (October 4, 2004)
  • K032018 — EASY PULSE II OXYGEN CONSERVER (August 25, 2003)

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)
  • 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)
  • K031686 — AEROMIST LT, MODEL HCS15004 (January 21, 2004)

FDA data resources