FDA 510(k)

Sonishield 100 Antimicrobial Ultrasound Gel

Номер K: K151070 · 2016-01-13

Дата решения2016-01-13

Код продуктаMUI

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Sonishield 100 Antimicrobial Ultrasound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Quotient Medical. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K151070. 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 Sonishield 100 Antimicrobial Ultrasound Gel?

Sonishield 100 Antimicrobial Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Quotient Medical. The 510(k) number is K151070.

When did Sonishield 100 Antimicrobial Ultrasound Gel receive FDA 510(k) clearance?

Sonishield 100 Antimicrobial Ultrasound Gel received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151070.

Who is the listed applicant for Sonishield 100 Antimicrobial Ultrasound Gel?

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

What is the FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel?

The FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel 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.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.

Официальный источник

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