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510(k) K121886

SAVINA 300 SAVINA 300, COUNTRY VARIANTS by Draeger Medical GmbH — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2014
Date Received
June 28, 2012
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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