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510(k) K944479

PM3300 INTERMITTENT VACUUM by Precision Medical, Inc. — Product Code KDP

K944479 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "PM3300 INTERMITTENT VACUUM". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1994
Date Received
September 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
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 KDP

  • K013976 — BOEHRINGER MRI SUCTION REGULATORY (January 8, 2002)
  • K942747 — MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (July 21, 1994)
  • K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (March 28, 1994)
  • K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS (July 27, 1993)
  • K922817 — PM3000 & PM3100 VACUUM REGULATOR (March 4, 1993)
  • K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR (October 19, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
  • K850200 — SUCTION REGULATOR 7700 SERIES (March 4, 1985)
  • K843591 — INTERCEPT (October 19, 1984)

FDA data resources