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FDA 510(k)

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)

N.º K: K160378 · 2017-08-25

SolicitanteBrh Medical , Ltd.
Fecha de decisión2017-08-25
Código de productoIMI
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is the device name listed in this FDA 510(k) record. The listed applicant is Brh Medical , Ltd.. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K160378. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)?

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Brh Medical , Ltd.. The 510(k) number is K160378.

When did BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) receive FDA 510(k) clearance?

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) received FDA 510(k) clearance on 2017-08-25, under 510(k) number K160378.

Who is the listed applicant for BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)?

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

What is the FDA product code for BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)?

The FDA product code for BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is IMI.

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Dispositivos relacionados (Código: IMI)

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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