LUCAS 3 Chest Compression System— 510(k) K173553

Substantially Equivalent

Jolife AB

FDA 510(k) clearance K173553 for LUCAS 3 Chest Compression System, Substantially Equivalent on 2018-02-08. Applicant: Jolife AB.

Clearance details

Applicant: Jolife AB
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2017-11-16
Decision date: 2018-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

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.