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510(k) K090781

HELIO2 BLENDER by Precision Medical, Inc. — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2009
Date Received
March 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

Other clearances by Precision Medical, Inc.

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  • K103324 — PRECISION LIQUID OXYGEN SYSTEM (April 21, 2011)
  • 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)
  • K032018 — EASY PULSE II OXYGEN CONSERVER (August 25, 2003)

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  • K173205 — Equinox Advantage (August 29, 2018)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)