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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 K160238
Device Name Airborne Phototherapy Light
Applicant
International Biomedical
8206 Cross Park Dr.
Austin,  TX  78754
Applicant Contact Amy Pieper
Correspondent
International Biomedical
8206 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact Amy Pieper
Regulation Number880.5700
Classification Product Code
LBI  
Date Received02/01/2016
Decision Date 06/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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