FDA 510(k)

BRILLIANT EverGlow 流量计

K号: K190597 · 2019-06-21

决定日期2019-06-21

产品代码EBF

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决定实质等同

器械摘要

BRILLIANT EverGlow Flow is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent AG. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K190597. 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 BRILLIANT EverGlow Flow?

BRILLIANT EverGlow Flow is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K190597.

When did BRILLIANT EverGlow Flow receive FDA 510(k) clearance?

BRILLIANT EverGlow Flow received FDA 510(k) clearance on 2019-06-21, under 510(k) number K190597.

Who is the listed applicant for BRILLIANT EverGlow Flow?

The FDA 510(k) record lists Coltene/Whaledent AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRILLIANT EverGlow Flow?

The FDA product code for BRILLIANT EverGlow Flow is EBF.

列明Coltene/Whaledent AG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。

K191385BRILLIANT COMPONEER K181500BRILLIANT Crios K160800DuoCem K152927BRILLIANT EVERGLOW

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