Home / 510(k) Clearances / K922817

510(k) K922817

PM3000 & PM3100 VACUUM REGULATOR by Precision Medical, Inc. — Product Code KDP

K922817 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "PM3000 & PM3100 VACUUM REGULATOR". The FDA issued a decision of Substantially Equivalent on March 4, 1993. 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
March 4, 1993
Date Received
June 11, 1992
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)
  • K944479 — PM3300 INTERMITTENT VACUUM (December 22, 1994)
  • 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)
  • 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