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510(k) K161718

MaxBlend 2, MaxBlend Lite by Maxtec, LLC — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2016
Date Received
June 22, 2016
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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