FDA 510(k)

AnemoCheck

Número K: K163215 · 2017-09-13

Data da decisão2017-09-13

Código do produtoKHG

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AnemoCheck is the device name listed in this FDA 510(k) record. The listed applicant is Sanguina, LLC. It received FDA 510(k) clearance on 2017-09-13 under 510(k) number K163215. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AnemoCheck?

AnemoCheck is a medical device that received FDA 510(k) clearance on 2017-09-13. The listed applicant is Sanguina, LLC. The 510(k) number is K163215.

When did AnemoCheck receive FDA 510(k) clearance?

AnemoCheck received FDA 510(k) clearance on 2017-09-13, under 510(k) number K163215.

Who is the listed applicant for AnemoCheck?

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

What is the FDA product code for AnemoCheck?

The FDA product code for AnemoCheck is KHG.

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Dispositivos Relacionados (Código: KHG)

K221508AnemoCheck HomeSanguina, Inc.

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