FDA 510(k)

超声传输凝胶

K号: K221999 · 2022-08-30

决定日期2022-08-30

产品代码MUI

咨询委员会RA

决定实质等同

器械摘要

Ultrasound Transmission Gels is the device name listed in this FDA 510(k) record. The listed applicant is Hony Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K221999. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultrasound Transmission Gels?

Ultrasound Transmission Gels is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Hony Medical Co., Ltd.. The 510(k) number is K221999.

When did Ultrasound Transmission Gels receive FDA 510(k) clearance?

Ultrasound Transmission Gels received FDA 510(k) clearance on 2022-08-30, under 510(k) number K221999.

Who is the listed applicant for Ultrasound Transmission Gels?

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

What is the FDA product code for Ultrasound Transmission Gels?

The FDA product code for Ultrasound Transmission Gels is MUI.

列明Hony Medical Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241789非灭菌超声传输凝胶 K241615探头探头盖 K221278探头探头盖

官方来源

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