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FDA 510(k)

Sonio Detect

K号: K240406 · 2024-04-26

申请人Sonio
决定日期2024-04-26
产品代码IYN
咨询委员会RA
决定实质等同

器械摘要

Sonio Detect is the device name listed in this FDA 510(k) record. The listed applicant is Sonio. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240406. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sonio Detect?

Sonio Detect is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Sonio. The 510(k) number is K240406.

When did Sonio Detect receive FDA 510(k) clearance?

Sonio Detect received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240406.

Who is the listed applicant for Sonio Detect?

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

What is the FDA product code for Sonio Detect?

The FDA product code for Sonio Detect is IYN.

相关临床试验

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列明Sonio为申报人的其他记录

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相关器械(代码:IYN)

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。

官方来源

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