CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003— 510(k) K053263

Substantially Equivalent

Cardionet, Inc.

FDA 510(k) clearance K053263 for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003, Substantially Equivalent on 2006-04-25. Applicant: Cardionet, Inc..

Clearance details

Applicant: Cardionet, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2005-11-22
Decision date: 2006-04-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.