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510(k) K142332

BT-400 by Bio-Med USA — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
August 20, 2014
Clearance Type
Traditional
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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Other clearances for product code LBI

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