FDA 510(k)

STAR 65

Número K: K172147 · 2018-05-25

RequerenteSkanray Technologies Pvt, Ltd.

Data da decisão2018-05-25

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

STAR 65 is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Pvt, Ltd.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K172147. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STAR 65?

STAR 65 is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Skanray Technologies Pvt, Ltd.. The 510(k) number is K172147.

When did STAR 65 receive FDA 510(k) clearance?

STAR 65 received FDA 510(k) clearance on 2018-05-25, under 510(k) number K172147.

Who is the listed applicant for STAR 65?

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

What is the FDA product code for STAR 65?

The FDA product code for STAR 65 is MWI.

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Fonte oficial

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