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FDA 510(k)

Máscara Quirúrgica Médica ADI

N.º K: K213347 · 2022-01-25

SolicitanteAsia Dynamics Inc., D/B/A Adi Medical
Fecha de decisión2022-01-25
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

ADI Medical Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Asia Dynamics Inc., D/B/A Adi Medical. It received FDA 510(k) clearance on 2022-01-25 under 510(k) number K213347. 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 ADI Medical Surgical Face Mask?

ADI Medical Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2022-01-25. The listed applicant is Asia Dynamics Inc., D/B/A Adi Medical. The 510(k) number is K213347.

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

ADI Medical Surgical Face Mask received FDA 510(k) clearance on 2022-01-25, under 510(k) number K213347.

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

The FDA 510(k) record lists Asia Dynamics Inc., D/B/A Adi Medical as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for ADI 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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