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FDA 510(k)

Disposable surgical face mask

N.º K: K220302 · 2022-11-16

SolicitanteShandong Aida Medical Products Co., Ltd.
Fecha de decisión2022-11-16
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable surgical face mask is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Aida Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K220302. 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 surgical face mask?

Disposable surgical face mask is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Shandong Aida Medical Products Co., Ltd.. The 510(k) number is K220302.

When did Disposable surgical face mask receive FDA 510(k) clearance?

Disposable surgical face mask received FDA 510(k) clearance on 2022-11-16, under 510(k) number K220302.

Who is the listed applicant for Disposable surgical face mask?

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

What is the FDA product code for Disposable surgical face mask?

The FDA product code for Disposable surgical face 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

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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