510(k) K061428— PMP4 APPLICATION

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2006-05-23
Decision date: 2006-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.