FDA 510(k)

WeSensor

Número K: K230916 · 2023-10-10

Data da decisão2023-10-10

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

WeSensor is the device name listed in this FDA 510(k) record. The listed applicant is Picopack, Inc.. It received FDA 510(k) clearance on 2023-10-10 under 510(k) number K230916. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WeSensor?

WeSensor is a medical device that received FDA 510(k) clearance on 2023-10-10. The listed applicant is Picopack, Inc.. The 510(k) number is K230916.

When did WeSensor receive FDA 510(k) clearance?

WeSensor received FDA 510(k) clearance on 2023-10-10, under 510(k) number K230916.

Who is the listed applicant for WeSensor?

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

What is the FDA product code for WeSensor?

The FDA product code for WeSensor is MUH.

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