K111745

Substantially Equivalent

KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER

Applicant: Card Guard Scientific Survival , Ltd.
Product 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

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.