FDA 510(k)

EBit Series Diagnostic Ultrasound System

Número K: K162172 · 2016-09-14

RequerenteChison Medical Imaging Co., Ltd.

Data da decisão2016-09-14

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EBit 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 2016-09-14 under 510(k) number K162172. 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 EBit Series Diagnostic Ultrasound System?

EBit Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Chison Medical Imaging Co., Ltd.. The 510(k) number is K162172.

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

EBit Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-09-14, under 510(k) number K162172.

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

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

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