FDA 510(k)

Electrodes Handpieces for Mygen V-1000 RF System

N.º K: K193355 · 2020-08-03

Fecha de decisión2020-08-03

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Electrodes Handpieces for Mygen V-1000 RF System is the device name listed in this FDA 510(k) record. The listed applicant is RF Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-08-03 under 510(k) number K193355. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Electrodes Handpieces for Mygen V-1000 RF System?

Electrodes Handpieces for Mygen V-1000 RF System is a medical device that received FDA 510(k) clearance on 2020-08-03. The listed applicant is RF Medical Co., Ltd.. The 510(k) number is K193355.

When did Electrodes Handpieces for Mygen V-1000 RF System receive FDA 510(k) clearance?

Electrodes Handpieces for Mygen V-1000 RF System received FDA 510(k) clearance on 2020-08-03, under 510(k) number K193355.

Who is the listed applicant for Electrodes Handpieces for Mygen V-1000 RF System?

The FDA 510(k) record lists RF Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrodes Handpieces for Mygen V-1000 RF System?

The FDA product code for Electrodes Handpieces for Mygen V-1000 RF System is GEI.

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Otros registros que enlistan a RF Medical Co., Ltd. como solicitante

K232763Electrode Handpieces (VCT, RFTV, BMDT series)K221277Generador de RF Mygen M-3004 K180999Mygen V-1000 RF System

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Fuente oficial

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