FDA 510(k)

Full Digital Colour Doppler Ultrasonic Diagnostic System

Номер K: K183041 · 2019-07-10

ЗаявительWuhan Zoncare Bio-medical Electronics Co., Ltd.

Дата решения2019-07-10

Код продуктаIYN

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Full Digital Colour Doppler Ultrasonic Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Zoncare Bio-medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K183041. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Full Digital Colour Doppler Ultrasonic Diagnostic System?

Full Digital Colour Doppler Ultrasonic Diagnostic System is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Wuhan Zoncare Bio-medical Electronics Co., Ltd.. The 510(k) number is K183041.

When did Full Digital Colour Doppler Ultrasonic Diagnostic System receive FDA 510(k) clearance?

Full Digital Colour Doppler Ultrasonic Diagnostic System received FDA 510(k) clearance on 2019-07-10, under 510(k) number K183041.

Who is the listed applicant for Full Digital Colour Doppler Ultrasonic Diagnostic System?

The FDA 510(k) record lists Wuhan Zoncare Bio-medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Full Digital Colour Doppler Ultrasonic Diagnostic System?

The FDA product code for Full Digital Colour Doppler Ultrasonic Diagnostic System is IYN.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: IYN)

Официальный источник

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