MINIATURIZE CHEST COMPRESSOR (MCC)— 510(k) K102068

Substantially Equivalent

Resuscitation International

FDA 510(k) clearance K102068 for MINIATURIZE CHEST COMPRESSOR (MCC), Substantially Equivalent on 2010-11-16. Applicant: Resuscitation International.

Clearance details

Applicant: Resuscitation International
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2010-07-23
Decision date: 2010-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.