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510(k) K053263

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 by Cardionet, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2006
Date Received
November 22, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Cardionet, Inc.

  • K093288 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION (April 8, 2010)
  • K072558 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 (December 5, 2007)
  • K063222 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 (November 14, 2006)
  • K052240 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 (October 19, 2005)
  • K012241 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 (February 1, 2002)
  • K003707 — CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A (May 16, 2001)

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