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FDA 510(k)

Ennova Self-adhesive Electrode

N.º K: K152648 · 2016-02-18

SolicitanteSuzhou Ennova Electronics Technology Co.,Ltd
Fecha de decisión2016-02-18
Código de productoGXY
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Ennova Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Ennova Electronics Technology Co.,Ltd. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K152648. 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 Ennova Self-adhesive Electrode?

Ennova Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Suzhou Ennova Electronics Technology Co.,Ltd. The 510(k) number is K152648.

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

Ennova Self-adhesive Electrode received FDA 510(k) clearance on 2016-02-18, under 510(k) number K152648.

Who is the listed applicant for Ennova Self-adhesive Electrode?

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

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

The FDA product code for Ennova 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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