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510(k) K200401

Apogee by Incoba Ltd D/B/A Dynaris — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2020
Date Received
February 18, 2020
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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