FDA 510(k)

Tixel i（TXLI0001）

K号: K240512 · 2024-11-04

决定日期2024-11-04

产品代码ORZ

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决定实质等同

器械摘要

Tixel i (TXLI0001) is the device name listed in this FDA 510(k) record. The listed applicant is Novoxel , Ltd.. It received FDA 510(k) clearance on 2024-11-04 under 510(k) number K240512. The device is classified under product code ORZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tixel i (TXLI0001)?

Tixel i (TXLI0001) is a medical device that received FDA 510(k) clearance on 2024-11-04. The listed applicant is Novoxel , Ltd.. The 510(k) number is K240512.

When did Tixel i (TXLI0001) receive FDA 510(k) clearance?

Tixel i (TXLI0001) received FDA 510(k) clearance on 2024-11-04, under 510(k) number K240512.

Who is the listed applicant for Tixel i (TXLI0001)?

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

What is the FDA product code for Tixel i (TXLI0001)?

The FDA product code for Tixel i (TXLI0001) is ORZ.

列明Novoxel , Ltd.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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