FDA 510(k)

Disposable Medical Face Mask

N.º K: K201470 · 2020-09-08

Fecha de decisión2020-09-08

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2020-09-08 under 510(k) number K201470. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Medical Face Mask?

Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2020-09-08. The listed applicant is Jkh USA, LLC. The 510(k) number is K201470.

When did Disposable Medical Face Mask receive FDA 510(k) clearance?

Disposable Medical Face Mask received FDA 510(k) clearance on 2020-09-08, under 510(k) number K201470.

Who is the listed applicant for Disposable Medical Face Mask?

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

What is the FDA product code for Disposable Medical Face Mask?

The FDA product code for Disposable Medical Face Mask is FXX.

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Otros registros que enlistan a Jkh USA, LLC como solicitante

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Fuente oficial

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