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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K121886
Device Name SAVINA 300 SAVINA 300, COUNTRY VARIANTS
Applicant
Draeger Medical GmbH
6 Tech Dr.
Andover,  MA  01810
Applicant Contact BETH ZIS
Correspondent
Draeger Medical GmbH
6 Tech Dr.
Andover,  MA  01810
Correspondent Contact BETH ZIS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/28/2012
Decision Date 08/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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