Fecha de decisión2023-01-19
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 Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K222252. 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 2023-01-19. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K222252.
When did Self-adhesive Electrode receive FDA 510(k) clearance?
Self-adhesive Electrode received FDA 510(k) clearance on 2023-01-19, under 510(k) number K222252.
Who is the listed applicant for Self-adhesive Electrode?
The FDA 510(k) record lists Shenzhen Roundwhale 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.
Ensayos clínicos relacionados
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Otros registros que enlistan a Shenzhen Roundwhale Technology Co. , Ltd. como solicitante
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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
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.