MODIFICATION TO LUCAS— 510(k) K062401

Substantially Equivalent

Jolife AB

FDA 510(k) clearance K062401 for MODIFICATION TO LUCAS, Substantially Equivalent on 2006-09-28. Applicant: Jolife AB.

Clearance details

Applicant: Jolife AB
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2006-08-16
Decision date: 2006-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.