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FDA 510(k)

Self-adhesive Electrode

N.º K: K222453 · 2022-11-04

SolicitanteGuangdong Comytens Medical Technology Co., Ltd.
Fecha de decisión2022-11-04
Código de productoGXY
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Comytens Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K222453. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Self-adhesive Electrode?

Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Guangdong Comytens Medical Technology Co., Ltd.. The 510(k) number is K222453.

When did Self-adhesive Electrode receive FDA 510(k) clearance?

Self-adhesive Electrode received FDA 510(k) clearance on 2022-11-04, under 510(k) number K222453.

Who is the listed applicant for Self-adhesive Electrode?

The FDA 510(k) record lists Guangdong Comytens Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Self-adhesive Electrode?

The FDA product code for Self-adhesive Electrode is GXY.

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Dispositivos relacionados (Código: GXY)

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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