FDA 510(k)

Elitone 设备

K号: K183585 · 2019-02-11

决定日期2019-02-11

产品代码QAJ

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决定实质等同

器械摘要

Elitone Device is the device name listed in this FDA 510(k) record. The listed applicant is Elidah, Inc.. It received FDA 510(k) clearance on 2019-02-11 under 510(k) number K183585. The device is classified under product code QAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elitone Device?

Elitone Device is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is Elidah, Inc.. The 510(k) number is K183585.

When did Elitone Device receive FDA 510(k) clearance?

Elitone Device received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183585.

Who is the listed applicant for Elitone Device?

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

What is the FDA product code for Elitone Device?

The FDA product code for Elitone Device is QAJ.

列明Elidah, 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。

K253285Elitone for Men K223884ELITONE 尿失禁设备

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。