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510(k) K142291

GMX Series Medical Air/Oxygen Blender by Gentec (Shanghai) Corporation — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2015
Date Received
August 18, 2014
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

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