ENERTRON CPR JACK— 510(k) K024215

Substantially Equivalent

Enertron Engineering Co.

FDA 510(k) clearance K024215 for ENERTRON CPR JACK, Substantially Equivalent on 2004-05-14. Applicant: Enertron Engineering Co..

Clearance details

Applicant: Enertron Engineering Co.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2002-12-20
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

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.