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510(k) K062555

EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G by Visgeneer, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2006
Date Received
August 30, 2006
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.

  • K122181 — EBCHEK BLOOD GLUCOSE MONITORING SYSTEM (August 15, 2013)
  • K091765 — EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM (January 19, 2010)

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