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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 K924930
Device Name EVITA
Applicant
DRAGER, INC.
4101 PLEASENT VALLEY ROAD,
SUITE 100
CHANTILLY,  VA  22021
Applicant Contact STEFAN FREMBGEN
Correspondent
DRAGER, INC.
4101 PLEASENT VALLEY ROAD,
SUITE 100
CHANTILLY,  VA  22021
Correspondent Contact STEFAN FREMBGEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/30/1992
Decision Date 01/10/1994
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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