FDA 510(k)

BB 8 鼻窦扩张套件

K号: K230258 · 2023-05-25

决定日期2023-05-25

产品代码LRC

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决定实质等同

器械摘要

BB 8 Sinus Dilation Kit is the device name listed in this FDA 510(k) record. The listed applicant is Excelent, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K230258. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BB 8 Sinus Dilation Kit?

BB 8 Sinus Dilation Kit is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Excelent, Inc.. The 510(k) number is K230258.

When did BB 8 Sinus Dilation Kit receive FDA 510(k) clearance?

BB 8 Sinus Dilation Kit received FDA 510(k) clearance on 2023-05-25, under 510(k) number K230258.

Who is the listed applicant for BB 8 Sinus Dilation Kit?

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

What is the FDA product code for BB 8 Sinus Dilation Kit?

The FDA product code for BB 8 Sinus Dilation Kit is LRC.

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。

BB 8 鼻窦扩张套件

器械摘要

常见问题

相关临床试验

相关器械（代码：LRC）

官方来源