FDA 510(k)

Symmed Elite 美容

K号: K230412 · 2023-04-13

决定日期2023-04-13

产品代码PBX

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决定实质等同

器械摘要

Symmed Elite Aesthetic is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K230412. 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 Symmed Elite Aesthetic?

Symmed Elite Aesthetic is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Termosalud. The 510(k) number is K230412.

When did Symmed Elite Aesthetic receive FDA 510(k) clearance?

Symmed Elite Aesthetic received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230412.

Who is the listed applicant for Symmed Elite Aesthetic?

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

What is the FDA product code for Symmed Elite Aesthetic?

The FDA product code for Symmed Elite Aesthetic is PBX.

列明Termosalud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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