CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR— 510(k) K081257

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

FDA 510(k) clearance K081257 for CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR, Substantially Equivalent on 2008-05-29. Applicant: Card Guard Scientific Survival , Ltd..

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2008-05-02
Decision date: 2008-05-29
Decision: Substantially Equivalent
Clearance type: Special
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.