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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 K950853
Device Name OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
Applicant
DRAGER, INC.
4101 PLEASENT VALLEY ROAD,
SUITE 100
CHANTILLY,  VA  22021
Applicant Contact HARALD KNEUER
Correspondent
DRAGER, INC.
4101 PLEASENT VALLEY ROAD,
SUITE 100
CHANTILLY,  VA  22021
Correspondent Contact HARALD KNEUER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/27/1995
Decision Date 11/05/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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