FDA 510(k)

MedWand

N.º K: K212975 · 2022-07-22

Fecha de decisión2022-07-22

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

MedWand is the device name listed in this FDA 510(k) record. The listed applicant is Medwand Solutions, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K212975. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MedWand?

MedWand is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Medwand Solutions, Inc.. The 510(k) number is K212975.

When did MedWand receive FDA 510(k) clearance?

MedWand received FDA 510(k) clearance on 2022-07-22, under 510(k) number K212975.

Who is the listed applicant for MedWand?

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

What is the FDA product code for MedWand?

The FDA product code for MedWand is MWI.

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Fuente oficial

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