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FDA 510(k)

Medical Face Mask

N.º K: K211353 · 2021-08-11

SolicitanteShenzhen Lyttop Healthcare Limited
Fecha de decisión2021-08-11
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lyttop Healthcare Limited. It received FDA 510(k) clearance on 2021-08-11 under 510(k) number K211353. 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 Face Mask?

Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-08-11. The listed applicant is Shenzhen Lyttop Healthcare Limited. The 510(k) number is K211353.

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

Medical Face Mask received FDA 510(k) clearance on 2021-08-11, under 510(k) number K211353.

Who is the listed applicant for Medical Face Mask?

The FDA 510(k) record lists Shenzhen Lyttop Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical 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

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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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