FDA 510(k)

LEDEX WL070+

K号: K163605 · 2017-01-19

决定日期2017-01-19

产品代码EBZ

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决定实质等同

器械摘要

LEDEX WL070+ is the device name listed in this FDA 510(k) record. The listed applicant is Dentmate Technology Co. , Ltd.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K163605. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LEDEX WL070+?

LEDEX WL070+ is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Dentmate Technology Co. , Ltd.. The 510(k) number is K163605.

When did LEDEX WL070+ receive FDA 510(k) clearance?

LEDEX WL070+ received FDA 510(k) clearance on 2017-01-19, under 510(k) number K163605.

Who is the listed applicant for LEDEX WL070+?

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

What is the FDA product code for LEDEX WL070+?

The FDA product code for LEDEX WL070+ is EBZ.

列明Dentmate Technology Co. , 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。

K221194LEDEX

官方来源

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