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FDA 510(k)

JianYu Surgical Mask

N.º K: K201754 · 2020-12-30

SolicitanteJiangsu Jianyu Health Medical Co., Ltd.
Fecha de decisión2020-12-30
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

JianYu Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jianyu Health Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K201754. 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 JianYu Surgical Mask?

JianYu Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Jiangsu Jianyu Health Medical Co., Ltd.. The 510(k) number is K201754.

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

JianYu Surgical Mask received FDA 510(k) clearance on 2020-12-30, under 510(k) number K201754.

Who is the listed applicant for JianYu Surgical Mask?

The FDA 510(k) record lists Jiangsu Jianyu Health Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JianYu Surgical Mask?

The FDA product code for JianYu Surgical Mask is FXX.

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Dispositivos relacionados (Código: FXX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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