FDA 510(k)

Sectum

K号: K202780 · 2021-07-30

决定日期2021-07-30

产品代码PBX

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决定实质等同

器械摘要

Sectum is the device name listed in this FDA 510(k) record. The listed applicant is Neauvia North America. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K202780. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sectum?

Sectum is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Neauvia North America. The 510(k) number is K202780.

When did Sectum receive FDA 510(k) clearance?

Sectum received FDA 510(k) clearance on 2021-07-30, under 510(k) number K202780.

Who is the listed applicant for Sectum?

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

What is the FDA product code for Sectum?

The FDA product code for Sectum is PBX.

列明Neauvia North America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。

K230077LaserME K213261EpilME

官方来源

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