FDA 510(k)

无菌和非无菌超声耦合剂

K号: K242167 · 2024-09-19

申请人Anhui Deepblue Medical Technology Co., Ltd.

决定日期2024-09-19

产品代码MUI

咨询委员会RA

决定实质等同

器械摘要

Sterile and Non-Sterile Ultrasonic Coupling Agent is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Deepblue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-09-19 under 510(k) number K242167. 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 Sterile and Non-Sterile Ultrasonic Coupling Agent?

Sterile and Non-Sterile Ultrasonic Coupling Agent is a medical device that received FDA 510(k) clearance on 2024-09-19. The listed applicant is Anhui Deepblue Medical Technology Co., Ltd.. The 510(k) number is K242167.

When did Sterile and Non-Sterile Ultrasonic Coupling Agent receive FDA 510(k) clearance?

Sterile and Non-Sterile Ultrasonic Coupling Agent received FDA 510(k) clearance on 2024-09-19, under 510(k) number K242167.

Who is the listed applicant for Sterile and Non-Sterile Ultrasonic Coupling Agent?

The FDA 510(k) record lists Anhui Deepblue Medical Technology 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 Ultrasonic Coupling Agent?

The FDA product code for Sterile and Non-Sterile Ultrasonic Coupling Agent is MUI.

列明Anhui Deepblue Medical Technology 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。

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官方来源

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