FDA 510(k)

WeSensor

N.º K: K230916 · 2023-10-10

Fecha de decisión2023-10-10

Código de productoMUH

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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