FDA 510(k)

奥迪风耳鸣模块

K号: K171243 · 2017-10-19

决定日期2017-10-19

产品代码KLW

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决定实质等同

器械摘要

audifon Tinnitus-Module is the device name listed in this FDA 510(k) record. The listed applicant is Audiofon USA, Inc.. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K171243. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the audifon Tinnitus-Module?

audifon Tinnitus-Module is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Audiofon USA, Inc.. The 510(k) number is K171243.

When did audifon Tinnitus-Module receive FDA 510(k) clearance?

audifon Tinnitus-Module received FDA 510(k) clearance on 2017-10-19, under 510(k) number K171243.

Who is the listed applicant for audifon Tinnitus-Module?

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

What is the FDA product code for audifon Tinnitus-Module?

The FDA product code for audifon Tinnitus-Module is KLW.

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。

奥迪风耳鸣模块

器械摘要

常见问题

相关临床试验

相关器械（代码：KLW）

官方来源