CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR— 510(k) K101639

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

FDA 510(k) clearance K101639 for CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR, Substantially Equivalent on 2010-06-25. Applicant: Card Guard Scientific Survival , Ltd..

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2010-06-10
Decision date: 2010-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Lakewood, CO, US

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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.