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

Name: FDA 510(k) clearance K153628
Creator: U.S. Food and Drug Administration
Published: 2016-01-30

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. Device class: 2.

Clearance details

Applicant: Resuscitation International, LLC
Product code: Code DRM
Device class: Class 2
Regulation: 21 CFR 870.5200
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 ↗

Recent devices under product code DRM

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K221700 — AutoPulse NXT Resuscitation System2023-03-09
K211289 — RMU-2000 Automated Chest Compression System2021-11-09
K173553 — LUCAS 3 Chest Compression System2018-02-08
K161768 — LUCAS 3 Chest Compression System2016-11-09
K141809 — RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM2014-10-27

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.