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510(k) K082521

EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM by Card Guard Scientific Survival , Ltd. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2009
Date Received
September 2, 2008
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

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  • K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (June 25, 2010)
  • K083174 — HEALTHEPOD (December 17, 2009)
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  • K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (December 18, 2007)
  • K061428 — PMP4 APPLICATION (October 16, 2006)
  • K061528 — SELFCHECK GLUCO (September 22, 2006)
  • K060911 — CG-6108 ARRHYTHMIA ECG EVENT RECORDER (August 22, 2006)

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