RMU-2000 Automated Chest Compression System— 510(k) K211289

Substantially Equivalent

Defibtech, LLC

FDA 510(k) clearance K211289 for RMU-2000 Automated Chest Compression System, Substantially Equivalent on 2021-11-09. Applicant: Defibtech, LLC.

Clearance details

Applicant: Defibtech, LLC
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2021-04-28
Decision date: 2021-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilford, CT, 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.