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510(k) K113007

BIONIME DIABETES MANAGEMENT SYSTEM VI.0 by Bionime Corporation — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2012
Date Received
October 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
Submission Type

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