FDA 510(k)

Sterile and Non-Sterile Ultrasound Gels

Номер K: K232957 · 2023-12-15

Дата решения2023-12-15

Код продуктаMUI

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Sterile and Non-Sterile Ultrasound Gels is the device name listed in this FDA 510(k) record. The listed applicant is Jianerkang Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232957. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Sterile and Non-Sterile Ultrasound Gels?

Sterile and Non-Sterile Ultrasound Gels is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Jianerkang Medical Co., Ltd.. The 510(k) number is K232957.

When did Sterile and Non-Sterile Ultrasound Gels receive FDA 510(k) clearance?

Sterile and Non-Sterile Ultrasound Gels received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232957.

Who is the listed applicant for Sterile and Non-Sterile Ultrasound Gels?

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

What is the FDA product code for Sterile and Non-Sterile Ultrasound Gels?

The FDA product code for Sterile and Non-Sterile Ultrasound Gels is MUI.

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: MUI)

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd.K252337EdgeFlow Gel PadEdgecare, Inc.K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.K211691Ultrast GelUltrast, Inc.

Официальный источник

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