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510(k) K042254

PMP4 SELFCHECK ECG by Card Guard Scientific Survival , Ltd. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2005
Date Received
August 20, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by Card Guard Scientific Survival , Ltd.

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  • K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (June 25, 2010)
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  • 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)
  • K061428 — PMP4 APPLICATION (October 16, 2006)
  • K061528 — SELFCHECK GLUCO (September 22, 2006)

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