FDA 510(k)

trophon 无线超声探头支架

K号: K241536 · 2024-09-27

决定日期2024-09-27

产品代码OUJ

咨询委员会RA

决定实质等同

器械摘要

trophon Wireless Ultrasound Probe Holder is the device name listed in this FDA 510(k) record. The listed applicant is Nanosonics Limited. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241536. The device is classified under product code OUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the trophon Wireless Ultrasound Probe Holder?

trophon Wireless Ultrasound Probe Holder is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Nanosonics Limited. The 510(k) number is K241536.

When did trophon Wireless Ultrasound Probe Holder receive FDA 510(k) clearance?

trophon Wireless Ultrasound Probe Holder received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241536.

Who is the listed applicant for trophon Wireless Ultrasound Probe Holder?

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

What is the FDA product code for trophon Wireless Ultrasound Probe Holder?

The FDA product code for trophon Wireless Ultrasound Probe Holder is OUJ.

列明Nanosonics Limited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。

K253267CORIS 系统 K173865trophon2

官方来源

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