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510(k) K061428

PMP4 APPLICATION by Card Guard Scientific Survival , Ltd. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2006
Date Received
May 23, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Card Guard Scientific Survival , Ltd.

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  • K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, (July 13, 2010)
  • K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (June 25, 2010)
  • K083174 — HEALTHEPOD (December 17, 2009)
  • K082521 — EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (January 16, 2009)
  • K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (May 29, 2008)
  • K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (December 18, 2007)
  • K061528 — SELFCHECK GLUCO (September 22, 2006)
  • K060911 — CG-6108 ARRHYTHMIA ECG EVENT RECORDER (August 22, 2006)

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