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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 K103589
Device Name NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
Applicant
NATUS MEDICAL INCORPORATED
5900 FIRST AVENUE SOUTH
SEATTLE,  WA  98108
Applicant Contact JULIE FREED
Correspondent
NATUS MEDICAL INCORPORATED
5900 FIRST AVENUE SOUTH
SEATTLE,  WA  98108
Correspondent Contact JULIE FREED
Regulation Number880.5700
Classification Product Code
LBI  
Date Received12/07/2010
Decision Date 05/13/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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