CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector— 510(k) K143359

Substantially Equivalent

Lifewatch Technologies , Ltd.

FDA 510(k) clearance K143359 for CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, Substantially Equivalent on 2015-09-11. Applicant: Lifewatch Technologies , Ltd..

Clearance details

Applicant: Lifewatch Technologies , Ltd.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2014-11-24
Decision date: 2015-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

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.