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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 K182178
Device Name neoBLUE blanket LED Phototherapy System
Applicant
Natus Medical Incorporated
5900 First Avenue South
Seattle,  WA  98108
Applicant Contact Judy Buckham
Correspondent
Natus Medical Incorporated
5900 First Avenue South
Seattle,  WA  98108
Correspondent Contact Judy Buckham
Regulation Number880.5700
Classification Product Code
LBI  
Date Received08/13/2018
Decision Date 12/13/2018
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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