HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100— 510(k) K062119

Substantially Equivalent

Medical Products Mfg., LLC

FDA 510(k) clearance K062119 for HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100, Substantially Equivalent on 2006-09-22. Applicant: Medical Products Mfg., LLC.

Clearance details

Applicant: Medical Products Mfg., LLC
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2006-07-25
Decision date: 2006-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, 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.