CPR HELPER— 510(k) K801946

Substantially Equivalent

Cardia Concepts Corp.

FDA 510(k) clearance K801946 for CPR HELPER, Substantially Equivalent on 1980-11-19. Applicant: Cardia Concepts Corp..

Clearance details

Applicant: Cardia Concepts Corp.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 1980-08-14
Decision date: 1980-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

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.