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FDA 510(k)

RMU-2000 Automated Chest Compression System

K-Number: K211289 · 2021-11-09

ApplicantDefibtech, LLC
Decision Date2021-11-09
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RMU-2000 Automated Chest Compression System is a medical device manufactured by Defibtech, LLC. It received FDA 510(k) clearance on 2021-11-09 under approval number K211289. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMU-2000 Automated Chest Compression System?

RMU-2000 Automated Chest Compression System is a medical device that received FDA 510(k) clearance on 2021-11-09. It is manufactured by Defibtech, LLC. The 510(k) number is K211289.

When was RMU-2000 Automated Chest Compression System approved by the FDA?

RMU-2000 Automated Chest Compression System received FDA 510(k) clearance on 2021-11-09, under approval number K211289.

What company makes RMU-2000 Automated Chest Compression System?

RMU-2000 Automated Chest Compression System is manufactured by Defibtech, LLC.

What is the FDA product code for RMU-2000 Automated Chest Compression System?

The FDA product code for RMU-2000 Automated Chest Compression System is DRM.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Defibtech, LLC

PMA P160032Automated external defibrillators (non-wearable)

Related Devices (Code: DRM)

K161768LUCAS 3 Chest Compression SystemJolife AB K153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC K173553LUCAS 3 Chest Compression SystemJolife AB K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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