FDA 510(k)

A-View

Número K: K170338 · 2017-05-16

Data da decisão2017-05-16

Código do produtoITX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

A-View is the device name listed in this FDA 510(k) record. The listed applicant is Stroke2prevent B.V.. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K170338. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the A-View?

A-View is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Stroke2prevent B.V.. The 510(k) number is K170338.

When did A-View receive FDA 510(k) clearance?

A-View received FDA 510(k) clearance on 2017-05-16, under 510(k) number K170338.

Who is the listed applicant for A-View?

The FDA 510(k) record lists Stroke2prevent B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-View?

The FDA product code for A-View is ITX.

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Fonte oficial

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