FDA 510(k), K012241, CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001

FDA 510(k), K012241, CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001

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510(K) Number: K012241
Device Name: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
Manufacturer: DONALD V CANAL
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: DSI
Classification Product Code: KXA
Date Received: 07/17/2001
Decision Date: 02/01/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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