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510(k) K220591

Proxima by Dynasthetics, LLC — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2022
Date Received
March 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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