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510(k) K221494

Quality Mix Blender, Oxymixer by Dehas Medical Systems GmbH — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2023
Date Received
May 23, 2022
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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