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510(k) K092484

HELIOX LOW FLOW SENTRY BLENDER by Cardinal Health 207, Inc. — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
August 13, 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 Cardinal Health 207, Inc.

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  • K081670 — THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK (October 9, 2008)
  • K081837 — AVEA VENTILATOR (August 13, 2008)

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