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

Substantially Equivalent

Cardionet, Inc.

FDA 510(k) clearance K012241 for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001, Substantially Equivalent on 2002-02-01. Applicant: Cardionet, Inc..

Clearance details

Applicant: Cardionet, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2001-07-17
Decision date: 2002-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.