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510(k) K083265

JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 by Agamatrix, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2009
Date Received
November 5, 2008
Clearance Type
Special
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

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  • K103544 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, R (December 7, 2011)
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  • K073573 — WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM (January 30, 2008)
  • K072413 — MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM (September 27, 2007)
  • K071393 — JAZZ BLOOD GLUCOSE MONITORING SYSTEM (July 20, 2007)

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