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510(k) K061528

SELFCHECK GLUCO by Card Guard Scientific Survival , Ltd. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2006
Date Received
June 2, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (December 18, 2007)
  • K061428 — PMP4 APPLICATION (October 16, 2006)
  • K060911 — CG-6108 ARRHYTHMIA ECG EVENT RECORDER (August 22, 2006)

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