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510(k) K160238

Airborne Phototherapy Light by International Biomedical — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2016
Date Received
February 1, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Neonatal Phototherapy
Device Class
Class II
Regulation Number
880.5700
Review Panel
HO
Submission Type

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