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FDA 510(k)

TOF-Cuff monitor

N.º K: K181894 · 2019-05-09

SolicitanteRgb Medical Devices SA
Fecha de decisión2019-05-09
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

TOF-Cuff monitor is the device name listed in this FDA 510(k) record. The listed applicant is Rgb Medical Devices SA. It received FDA 510(k) clearance on 2019-05-09 under 510(k) number K181894. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TOF-Cuff monitor?

TOF-Cuff monitor is a medical device that received FDA 510(k) clearance on 2019-05-09. The listed applicant is Rgb Medical Devices SA. The 510(k) number is K181894.

When did TOF-Cuff monitor receive FDA 510(k) clearance?

TOF-Cuff monitor received FDA 510(k) clearance on 2019-05-09, under 510(k) number K181894.

Who is the listed applicant for TOF-Cuff monitor?

The FDA 510(k) record lists Rgb Medical Devices SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOF-Cuff monitor?

The FDA product code for TOF-Cuff monitor is DXN.

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Dispositivos relacionados (Código: DXN)

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Fuente oficial

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