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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 K961687
Device Name EVITA 4
Applicant
DRAGER, INC.
4101-100 PLEASANT VALLEY RD.
CHANTILLY,  VA  22021
Applicant Contact HARALD KNEUER
Correspondent
DRAGER, INC.
4101-100 PLEASANT VALLEY RD.
CHANTILLY,  VA  22021
Correspondent Contact HARALD KNEUER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/01/1996
Decision Date 12/13/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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