FDA 510(k)

TRIOS Ready Tip

K号: K242103 · 2025-04-04

决定日期2025-04-04

产品代码NBL

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决定实质等同

器械摘要

TRIOS Ready Tip is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape TRIOS A/S. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242103. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TRIOS Ready Tip?

TRIOS Ready Tip is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is 3Shape TRIOS A/S. The 510(k) number is K242103.

When did TRIOS Ready Tip receive FDA 510(k) clearance?

TRIOS Ready Tip received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242103.

Who is the listed applicant for TRIOS Ready Tip?

The FDA 510(k) record lists 3Shape TRIOS A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIOS Ready Tip?

The FDA product code for TRIOS Ready Tip is NBL.

列明3Shape TRIOS A/S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。

K260082TRIOS Dx (R1)K221249L1P-1F (TRIOS 5)

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。