FDA 510(k)

Enlight 2100 (TPL-E2103-0)

K号: K250464 · 2025-09-10

决定日期2025-09-10

产品代码QEB

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决定实质等同

器械摘要

Enlight 2100 (TPL-E2103-0) 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 2025-09-10 under 510(k) number K250464. 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 (TPL-E2103-0)?

Enlight 2100 (TPL-E2103-0) is a medical device that received FDA 510(k) clearance on 2025-09-10. The listed applicant is Timpel S.A.. The 510(k) number is K250464.

When did Enlight 2100 (TPL-E2103-0) receive FDA 510(k) clearance?

Enlight 2100 (TPL-E2103-0) received FDA 510(k) clearance on 2025-09-10, under 510(k) number K250464.

Who is the listed applicant for Enlight 2100 (TPL-E2103-0)?

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 (TPL-E2103-0)?

The FDA product code for Enlight 2100 (TPL-E2103-0) 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。

K222897Enlight 2100 K211135Enlight 2100

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