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510(k) K180779

Savina 300 by Dragerwerk AG & CO Kgaa — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2019
Date Received
March 26, 2018
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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