KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER— 510(k) K111745

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

FDA 510(k) clearance K111745 for KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER, Substantially Equivalent on 2011-08-01. Applicant: Card Guard Scientific Survival , Ltd..

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2011-06-21
Decision date: 2011-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Lakewood, CO, US

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.