ROSC-U Mini Chest Compressor (RMCC)— 510(k) K153628

Substantially Equivalent

Resuscitation International, LLC

FDA 510(k) clearance K153628 for ROSC-U Mini Chest Compressor (RMCC), Substantially Equivalent on 2016-01-30. Applicant: Resuscitation International, LLC.

Clearance details

Applicant: Resuscitation International, LLC
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2015-12-18
Decision date: 2016-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, 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.