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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, infant radiant
510(k) Number K971198
Device Name BABYTHERM 8004 BABYTHERM 8010
Applicant
DRAGER, INC.
4101 PLEASENT VALLEY ROAD,
SUITE 100
CHANTILLY,  VA  22021
Applicant Contact HERALD KNEUER
Correspondent
DRAGER, INC.
4101 PLEASENT VALLEY ROAD,
SUITE 100
CHANTILLY,  VA  22021
Correspondent Contact HERALD KNEUER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/31/1997
Decision Date 10/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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