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FDA 510(k)

WYZ Surgical Mask

N.º K: K211576 · 2021-08-19

SolicitanteWyz Medical Supplies, LLC
Fecha de decisión2021-08-19
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

WYZ Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wyz Medical Supplies, LLC. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211576. 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 WYZ Surgical Mask?

WYZ Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Wyz Medical Supplies, LLC. The 510(k) number is K211576.

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

WYZ Surgical Mask received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211576.

Who is the listed applicant for WYZ Surgical Mask?

The FDA 510(k) record lists Wyz Medical Supplies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WYZ Surgical Mask?

The FDA product code for WYZ 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

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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