FDA 510(k)

Ultrasound System 1300

N.º K: K231764 · 2023-10-23

Fecha de decisión2023-10-23

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ultrasound System 1300 is the device name listed in this FDA 510(k) record. The listed applicant is Bk Medical Aps. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K231764. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ultrasound System 1300?

Ultrasound System 1300 is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is Bk Medical Aps. The 510(k) number is K231764.

When did Ultrasound System 1300 receive FDA 510(k) clearance?

Ultrasound System 1300 received FDA 510(k) clearance on 2023-10-23, under 510(k) number K231764.

Who is the listed applicant for Ultrasound System 1300?

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

What is the FDA product code for Ultrasound System 1300?

The FDA product code for Ultrasound System 1300 is IYN.

Ensayos clínicos relacionados

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Otros registros que enlistan a Bk Medical Aps como solicitante

K223830Ultrasound System 2300 K222441Ultrasound System 2300 K180737Ultrasound Scanner System bk2300 K173569Ultrasound System 1300 K161960bk2300

Dispositivos relacionados (Código: IYN)

Fuente oficial

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