FDA 510(k)

耳鸣声发生器模块

K号: K180495 · 2018-11-30

决定日期2018-11-30

产品代码KLW

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决定实质等同

器械摘要

Tinnitus Sound Generator Module is the device name listed in this FDA 510(k) record. The listed applicant is GN Hearing A/S. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K180495. 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 Tinnitus Sound Generator Module?

Tinnitus Sound Generator Module is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is GN Hearing A/S. The 510(k) number is K180495.

When did Tinnitus Sound Generator Module receive FDA 510(k) clearance?

Tinnitus Sound Generator Module received FDA 510(k) clearance on 2018-11-30, under 510(k) number K180495.

Who is the listed applicant for Tinnitus Sound Generator Module?

The FDA 510(k) record lists GN Hearing A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tinnitus Sound Generator Module?

The FDA product code for Tinnitus Sound Generator Module is KLW.

列明GN Hearing A/S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。

K254108Jabra Enhance Select 自适应型（Jabra Enhance Select 550）K213424Jabra Enhance Plus K193303耳鸣声发生器模块 K181586耳鸣声发生器模块

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。