FDA 510(k)

Enlight 2100

K号: K211135 · 2022-01-06

决定日期2022-01-06

产品代码QEB

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决定实质等同

器械摘要

Enlight 2100 is the device name listed in this FDA 510(k) record. The listed applicant is Timpel S.A.. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K211135. The device is classified under product code QEB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Enlight 2100?

Enlight 2100 is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Timpel S.A.. The 510(k) number is K211135.

When did Enlight 2100 receive FDA 510(k) clearance?

Enlight 2100 received FDA 510(k) clearance on 2022-01-06, under 510(k) number K211135.

Who is the listed applicant for Enlight 2100?

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

What is the FDA product code for Enlight 2100?

The FDA product code for Enlight 2100 is QEB.

列明Timpel S.A.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。

K250464Enlight 2100 (TPL-E2103-0)K222897Enlight 2100

官方来源

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