FDA 510(k)

VX650

Número K: K202221 · 2021-01-29

Data da decisão2021-01-29

Código do produtoHKI

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

VX650 is the device name listed in this FDA 510(k) record. The listed applicant is Luneau Technology Operations. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K202221. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VX650?

VX650 is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Luneau Technology Operations. The 510(k) number is K202221.

When did VX650 receive FDA 510(k) clearance?

VX650 received FDA 510(k) clearance on 2021-01-29, under 510(k) number K202221.

Who is the listed applicant for VX650?

The FDA 510(k) record lists Luneau Technology Operations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VX650?

The FDA product code for VX650 is HKI.

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