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FDA 510(k)

INTAI Surgical Mask (non-sterile)

N.º K: K210422 · 2022-03-30

SolicitanteIntai Technology Corp.
Fecha de decisión2022-03-30
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

INTAI Surgical Mask (non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Intai Technology Corp.. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K210422. 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 INTAI Surgical Mask (non-sterile)?

INTAI Surgical Mask (non-sterile) is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Intai Technology Corp.. The 510(k) number is K210422.

When did INTAI Surgical Mask (non-sterile) receive FDA 510(k) clearance?

INTAI Surgical Mask (non-sterile) received FDA 510(k) clearance on 2022-03-30, under 510(k) number K210422.

Who is the listed applicant for INTAI Surgical Mask (non-sterile)?

The FDA 510(k) record lists Intai Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTAI Surgical Mask (non-sterile)?

The FDA product code for INTAI Surgical Mask (non-sterile) 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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