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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K954611
Device Name DRAGER PT4000 PHOTOTHERAPY SYSTEM
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 Number880.5700
Classification Product Code
LBI  
Date Received10/04/1995
Decision Date 12/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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