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FDA 510(k)

Phyziofit Medical Surgical Mask

N.º K: K201868 · 2021-02-22

SolicitanteWellpower Sporting Goods Co., Ltd.
Fecha de decisión2021-02-22
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Phyziofit Medical Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wellpower Sporting Goods Co., Ltd.. It received FDA 510(k) clearance on 2021-02-22 under 510(k) number K201868. 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 Phyziofit Medical Surgical Mask?

Phyziofit Medical Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Wellpower Sporting Goods Co., Ltd.. The 510(k) number is K201868.

When did Phyziofit Medical Surgical Mask receive FDA 510(k) clearance?

Phyziofit Medical Surgical Mask received FDA 510(k) clearance on 2021-02-22, under 510(k) number K201868.

Who is the listed applicant for Phyziofit Medical Surgical Mask?

The FDA 510(k) record lists Wellpower Sporting Goods Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phyziofit Medical Surgical Mask?

The FDA product code for Phyziofit Medical Surgical Mask is FXX.

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Dispositivos relacionados (Código: FXX)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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