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510(k) K172365

Panoramic Oxygen Mask (POM) by Pom Medical, LLC — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2018
Date Received
August 4, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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