CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR— 510(k) K071995

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

FDA 510(k) clearance K071995 for CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, Substantially Equivalent on 2007-12-18. Applicant: Card Guard Scientific Survival , Ltd..

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2007-07-20
Decision date: 2007-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

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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.