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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 K180779
Device Name Savina 300
Applicant
Dragerwerk AG & CO. KGaA
Moislinger Allee 53-55
Lubeck,  DE 23558
Applicant Contact Dr. Bettina Mobius
Correspondent
Dragerwerk AG & CO. KGaA
Moislinger Allee 53-55
Lubeck,  DE 23558
Correspondent Contact Dr. Bettina Mobius
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/26/2018
Decision Date 01/17/2019
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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