CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004— 510(k) K063222

Substantially Equivalent

Cardionet, Inc.

FDA 510(k) clearance K063222 for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004, Substantially Equivalent on 2006-11-14. Applicant: Cardionet, Inc..

Clearance details

Applicant: Cardionet, Inc.
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2006-10-24
Decision date: 2006-11-14
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

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.