CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002— 510(k) K052240

Substantially Equivalent

Cardionet, Inc.

FDA 510(k) clearance K052240 for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002, Substantially Equivalent on 2005-10-19. Applicant: Cardionet, Inc..

Clearance details

Applicant: Cardionet, Inc.
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2005-08-17
Decision date: 2005-10-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.