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FDA 510(k)

Máscara Quirúrgica Médica (Tipo Plano)

N.º K: K220824 · 2022-05-19

SolicitanteHunan Chopard Medical Devices Co., Ltd.
Fecha de decisión2022-05-19
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Surgical Mask (Planar type) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Chopard Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K220824. 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 Medical Surgical Mask (Planar type)?

Medical Surgical Mask (Planar type) is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Hunan Chopard Medical Devices Co., Ltd.. The 510(k) number is K220824.

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

Medical Surgical Mask (Planar type) received FDA 510(k) clearance on 2022-05-19, under 510(k) number K220824.

Who is the listed applicant for Medical Surgical Mask (Planar type)?

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

What is the FDA product code for Medical Surgical Mask (Planar type)?

The FDA product code for Medical Surgical Mask (Planar type) 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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