FDA 510(k)

SonoBook Series Diagnostic Ultrasound System

Número K: K170374 · 2017-06-06

RequerenteChison Medical Imaging Co., Ltd.

Data da decisão2017-06-06

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SonoBook Series Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Chison Medical Imaging Co., Ltd.. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K170374. 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 SonoBook Series Diagnostic Ultrasound System?

SonoBook Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Chison Medical Imaging Co., Ltd.. The 510(k) number is K170374.

When did SonoBook Series Diagnostic Ultrasound System receive FDA 510(k) clearance?

SonoBook Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170374.

Who is the listed applicant for SonoBook Series Diagnostic Ultrasound System?

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

What is the FDA product code for SonoBook Series Diagnostic Ultrasound System?

The FDA product code for SonoBook Series Diagnostic Ultrasound System is IYN.

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