FDA 510(k)

RMU-2000 Automated Chest Compression System

Número K: K211289 · 2021-11-09

Data da decisão2021-11-09

Código do produtoDRM

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Defibtech, LLC. The 510(k) number is K211289.

When did RMU-2000 Automated Chest Compression System receive FDA 510(k) clearance?

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

Who is the listed applicant for RMU-2000 Automated Chest Compression System?

The FDA 510(k) record lists Defibtech, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

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Dispositivos Relacionados (Código: DRM)

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

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