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FDA 510(k)

Disposable Medical Surgical Face Mask

N.º K: K203200 · 2021-06-16

SolicitanteGuangdong Haiou Medical Apparatus Co., Ltd.
Fecha de decisión2021-06-16
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Medical Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Haiou Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K203200. 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 Surgical Face Mask?

Disposable Medical Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Guangdong Haiou Medical Apparatus Co., Ltd.. The 510(k) number is K203200.

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

Disposable Medical Surgical Face Mask received FDA 510(k) clearance on 2021-06-16, under 510(k) number K203200.

Who is the listed applicant for Disposable Medical Surgical Face Mask?

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

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

The FDA product code for Disposable Medical 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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