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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
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