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510(k) K901831

PRECISION MEDICAL OXYGEN REGULATOR by Precision Medical, Inc. — Product Code CAN

K901831 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "PRECISION MEDICAL OXYGEN REGULATOR". The FDA issued a decision of Substantially Equivalent on August 14, 1990. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1990
Date Received
April 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
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 CAN

  • K162811 — MR Conditional CGA 870 (March 2, 2017)
  • K080243 — PORTABLE OXYGEN UNIT SCA900 (April 7, 2009)
  • K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (October 25, 2006)
  • K061785 — CYL-FIL OXYGEN SYSTEM (September 7, 2006)
  • K950777 — OXYGEN REGULATOR (April 14, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932006 — 1500 SERIES REGULATOR (October 25, 1993)
  • K921125 — AMBU OXYGEN REGULATOR (September 17, 1992)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)

FDA data resources