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510(k) K122181

EBCHEK BLOOD GLUCOSE MONITORING SYSTEM by Visgeneer, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2013
Date Received
July 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Visgeneer, Inc.

  • K091765 — EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM (January 19, 2010)
  • K062555 — EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G (December 27, 2006)

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