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FDA 510(k)

Epione

K号: K223758 · 2023-05-03

决定日期2023-05-03
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

Epione is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Surgical Sas. It received FDA 510(k) clearance on 2023-05-03 under 510(k) number K223758. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Epione?

Epione is a medical device that received FDA 510(k) clearance on 2023-05-03. The listed applicant is Quantum Surgical Sas. The 510(k) number is K223758.

When did Epione receive FDA 510(k) clearance?

Epione received FDA 510(k) clearance on 2023-05-03, under 510(k) number K223758.

Who is the listed applicant for Epione?

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

What is the FDA product code for Epione?

The FDA product code for Epione is JAK.

相关临床试验

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列明Quantum Surgical Sas为申报人的其他记录

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相关器械(代码:JAK)

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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