FDA 510(k)

Elevo 呼吸干预套装

K号: K213475 · 2022-01-27

决定日期2022-01-27

产品代码LRK

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Elevo Snoring Intervention Set is the device name listed in this FDA 510(k) record. The listed applicant is Zelegent, Inc.. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K213475. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elevo Snoring Intervention Set?

Elevo Snoring Intervention Set is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Zelegent, Inc.. The 510(k) number is K213475.

When did Elevo Snoring Intervention Set receive FDA 510(k) clearance?

Elevo Snoring Intervention Set received FDA 510(k) clearance on 2022-01-27, under 510(k) number K213475.

Who is the listed applicant for Elevo Snoring Intervention Set?

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

What is the FDA product code for Elevo Snoring Intervention Set?

The FDA product code for Elevo Snoring Intervention Set is LRK.

列明Zelegent, Inc.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。

K181107Elevo® 套件呼吸干预设备

官方来源

在 FDA 数据库中查看 →

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。