FDA 510(k)

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory

Número K: K202742 · 2021-01-25

Data da decisão2021-01-25

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory is the device name listed in this FDA 510(k) record. The listed applicant is Viasonix , Ltd.. It received FDA 510(k) clearance on 2021-01-25 under 510(k) number K202742. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory?

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory is a medical device that received FDA 510(k) clearance on 2021-01-25. The listed applicant is Viasonix , Ltd.. The 510(k) number is K202742.

When did Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory receive FDA 510(k) clearance?

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory received FDA 510(k) clearance on 2021-01-25, under 510(k) number K202742.

Who is the listed applicant for Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory?

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

What is the FDA product code for Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory?

The FDA product code for Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory is IYN.

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Outros registros que listam Viasonix , Ltd. como candidato(a)

K242662Falcon/Xpress (Falcon/Xpress)K192607LiteWalk K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAX K170859Dolphin/IQ and Dolphin/4D

Dispositivos Relacionados (Código: IYN)

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