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510(k) K222024

Evita V800, Evita V600 by Draegerwerk AG & CO Kgaa — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2023
Date Received
July 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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