FDA 510(k)

Estelite通用流量

K号: K180613 · 2018-07-12

决定日期2018-07-12

产品代码EBF

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决定实质等同

器械摘要

Estelite Universal Flow is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2018-07-12 under 510(k) number K180613. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Estelite Universal Flow?

Estelite Universal Flow is a medical device that received FDA 510(k) clearance on 2018-07-12. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K180613.

When did Estelite Universal Flow receive FDA 510(k) clearance?

Estelite Universal Flow received FDA 510(k) clearance on 2018-07-12, under 510(k) number K180613.

Who is the listed applicant for Estelite Universal Flow?

The FDA 510(k) record lists Tokuyama Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Estelite Universal Flow?

The FDA product code for Estelite Universal Flow is EBF.

列明Tokuyama Dental Corporation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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