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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 K970165
Device Name EVITA 2 DURA
Applicant
DRAGER, INC.
4101 PLEASENT VALLEY ROAD,
SUITE 100
CHANTILLY,  VA  22021
Applicant Contact HAROLD KNEUER
Correspondent
DRAGER, INC.
4101 PLEASENT VALLEY ROAD,
SUITE 100
CHANTILLY,  VA  22021
Correspondent Contact HAROLD KNEUER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/16/1997
Decision Date 08/26/1997
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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