FDA 510(k)

亲密玫瑰阴道扩张器

K号: K241748 · 2024-08-14

决定日期2024-08-14

产品代码HDX

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决定实质等同

器械摘要

Intimate Rose Vaginal Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Plus EV Holdings Dba Intimate Rose. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K241748. The device is classified under product code HDX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intimate Rose Vaginal Dilators?

Intimate Rose Vaginal Dilators is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Plus EV Holdings Dba Intimate Rose. The 510(k) number is K241748.

When did Intimate Rose Vaginal Dilators receive FDA 510(k) clearance?

Intimate Rose Vaginal Dilators received FDA 510(k) clearance on 2024-08-14, under 510(k) number K241748.

Who is the listed applicant for Intimate Rose Vaginal Dilators?

The FDA 510(k) record lists Plus EV Holdings Dba Intimate Rose as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intimate Rose Vaginal Dilators?

The FDA product code for Intimate Rose Vaginal Dilators is HDX.

列明Plus EV Holdings Dba Intimate Rose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。

K231430亲密玫瑰阴道扩张器 K193364亲密玫瑰凯格尔锻炼系统

官方来源

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