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510(k) K200031

Neonatal Phototherapy System by Avalon Biomedical (Shenzhen) Limited — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2020
Date Received
January 7, 2020
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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