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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 K051869
Device Name NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
Applicant
NATUS MEDICAL, INC.
1501 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Applicant Contact LUANNE NG
Correspondent
NATUS MEDICAL, INC.
1501 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Correspondent Contact LUANNE NG
Regulation Number880.5700
Classification Product Code
LBI  
Date Received07/11/2005
Decision Date 10/07/2005
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
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