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510(k) K241366

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) by Dehas Medical Systems GmbH — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2024
Date Received
May 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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