FDA 510(k)

AnemoCheck Home

Número K: K221508 · 2023-09-29

Data da decisão2023-09-29

Código do produtoKHG

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AnemoCheck Home is the device name listed in this FDA 510(k) record. The listed applicant is Sanguina, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K221508. 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 Home?

AnemoCheck Home is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Sanguina, Inc.. The 510(k) number is K221508.

When did AnemoCheck Home receive FDA 510(k) clearance?

AnemoCheck Home received FDA 510(k) clearance on 2023-09-29, under 510(k) number K221508.

Who is the listed applicant for AnemoCheck Home?

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

What is the FDA product code for AnemoCheck Home?

The FDA product code for AnemoCheck Home is KHG.

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Dispositivos Relacionados (Código: KHG)

K163215AnemoCheckSanguina, LLC

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