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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
Predetermined Change
Control Plan Authorized		 No
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