FDA 510(k)

Star RF Electrode, VIVA RF Electrode

Número K: K203795 · 2021-04-01

Data da decisão2021-04-01

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Star RF Electrode, VIVA RF Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Starmed Co., Ltd.. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K203795. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Star RF Electrode, VIVA RF Electrode?

Star RF Electrode, VIVA RF Electrode is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K203795.

When did Star RF Electrode, VIVA RF Electrode receive FDA 510(k) clearance?

Star RF Electrode, VIVA RF Electrode received FDA 510(k) clearance on 2021-04-01, under 510(k) number K203795.

Who is the listed applicant for Star RF Electrode, VIVA RF Electrode?

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

What is the FDA product code for Star RF Electrode, VIVA RF Electrode?

The FDA product code for Star RF Electrode, VIVA RF Electrode is GEI.

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Fonte oficial

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