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FDA 510(k)

TAIJI Professional Series Level 3 Surgical Face Mask

N.º K: K211861 · 2021-07-28

SolicitanteTaiji Medical Supplies, Inc.
Fecha de decisión2021-07-28
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

TAIJI Professional Series Level 3 Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Taiji Medical Supplies, Inc.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211861. 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 TAIJI Professional Series Level 3 Surgical Face Mask?

TAIJI Professional Series Level 3 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Taiji Medical Supplies, Inc.. The 510(k) number is K211861.

When did TAIJI Professional Series Level 3 Surgical Face Mask receive FDA 510(k) clearance?

TAIJI Professional Series Level 3 Surgical Face Mask received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211861.

Who is the listed applicant for TAIJI Professional Series Level 3 Surgical Face Mask?

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

What is the FDA product code for TAIJI Professional Series Level 3 Surgical Face Mask?

The FDA product code for TAIJI Professional Series Level 3 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

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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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