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510(k) K113232

MAXMIXING BLOCK by Maxtec, Inc. — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2012
Date Received
November 2, 2011
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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  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)