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510(k) K203210

Invacare Platinum 5NXG Oxygen Concentrator by Invacare Corporation — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2021
Date Received
October 30, 2020
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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