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510(k) K132489

INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) by Inogen, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2014
Date Received
August 8, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

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