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510(k) K930509

PM PUMP COMPRESSOR by Precision Medical, Inc. — Product Code BTI

K930509 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "PM PUMP COMPRESSOR". The FDA issued a decision of Substantially Equivalent on October 28, 1994. 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
October 28, 1994
Date Received
February 1, 1993
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)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041122 — PRECISION LIQUID OXYGEN SYSTEM (October 4, 2004)

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