FDA 510(k)

ROSC-U Mini Chest Compressor (RMCC)

N.º K: K153628 · 2016-01-30

SolicitanteResuscitation International, LLC

Fecha de decisión2016-01-30

Código de productoDRM

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ROSC-U Mini Chest Compressor (RMCC) is the device name listed in this FDA 510(k) record. The listed applicant is Resuscitation International, LLC. It received FDA 510(k) clearance on 2016-01-30 under 510(k) number K153628. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ROSC-U Mini Chest Compressor (RMCC)?

ROSC-U Mini Chest Compressor (RMCC) is a medical device that received FDA 510(k) clearance on 2016-01-30. The listed applicant is Resuscitation International, LLC. The 510(k) number is K153628.

When did ROSC-U Mini Chest Compressor (RMCC) receive FDA 510(k) clearance?

ROSC-U Mini Chest Compressor (RMCC) received FDA 510(k) clearance on 2016-01-30, under 510(k) number K153628.

Who is the listed applicant for ROSC-U Mini Chest Compressor (RMCC)?

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

What is the FDA product code for ROSC-U Mini Chest Compressor (RMCC)?

The FDA product code for ROSC-U Mini Chest Compressor (RMCC) is DRM.

Ensayos clínicos relacionados

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Fuente oficial

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