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510(k) K132543

INFANT INCUBATOR by Bistos Co., Ltd. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2014
Date Received
August 13, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

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