FDA 510(k)

K3900 Ultrasound Imaging System

Номер K: K230511 · 2023-10-25

ЗаявительMaui Imaging

Дата решения2023-10-25

Код продуктаIYO

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

K3900 Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Maui Imaging. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K230511. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the K3900 Ultrasound Imaging System?

K3900 Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Maui Imaging. The 510(k) number is K230511.

When did K3900 Ultrasound Imaging System receive FDA 510(k) clearance?

K3900 Ultrasound Imaging System received FDA 510(k) clearance on 2023-10-25, under 510(k) number K230511.

Who is the listed applicant for K3900 Ultrasound Imaging System?

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

What is the FDA product code for K3900 Ultrasound Imaging System?

The FDA product code for K3900 Ultrasound Imaging System is IYO.

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: IYO)

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Официальный источник

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