FDA 510(k)

Ultrasound Scanner System bk2300

Número K: K180737 · 2018-08-01

Data da decisão2018-08-01

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ultrasound Scanner System bk2300 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 2018-08-01 under 510(k) number K180737. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ultrasound Scanner System bk2300?

Ultrasound Scanner System bk2300 is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Bk Medical Aps. The 510(k) number is K180737.

When did Ultrasound Scanner System bk2300 receive FDA 510(k) clearance?

Ultrasound Scanner System bk2300 received FDA 510(k) clearance on 2018-08-01, under 510(k) number K180737.

Who is the listed applicant for Ultrasound Scanner System bk2300?

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 Scanner System bk2300?

The FDA product code for Ultrasound Scanner System bk2300 is IYN.

Ensaios clínicos relacionados

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Outros registros que listam Bk Medical Aps como candidato(a)

K231764Ultrasound System 1300 K223830Ultrasound System 2300 K222441Ultrasound System 2300 K173569Ultrasound System 1300 K161960bk2300

Dispositivos Relacionados (Código: IYN)

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