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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 K160745
Device Name neoBLUE compact LED Phototherapy System
Applicant
Natus Medical Incorporated
5900 First Ave. S.
Seattle,  WA  98108
Applicant Contact THERESE LEGGIERE
Correspondent
Natus Medical Incorporated
5900 First Ave. S.
Seattle,  WA  98108
Correspondent Contact THERESE LEGGIERE
Regulation Number880.5700
Classification Product Code
LBI  
Date Received03/18/2016
Decision Date 12/12/2016
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
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