FDA 510(k)

维斯比医疗性健康

K号: K200748 · 2021-08-26

决定日期2021-08-26

产品代码QEP

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决定实质等同

器械摘要

Visby Medical Sexual Health is the device name listed in this FDA 510(k) record. The listed applicant is Visby Medical. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K200748. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Visby Medical Sexual Health?

Visby Medical Sexual Health is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Visby Medical. The 510(k) number is K200748.

When did Visby Medical Sexual Health receive FDA 510(k) clearance?

Visby Medical Sexual Health received FDA 510(k) clearance on 2021-08-26, under 510(k) number K200748.

Who is the listed applicant for Visby Medical Sexual Health?

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

What is the FDA product code for Visby Medical Sexual Health?

The FDA product code for Visby Medical Sexual Health is QEP.

列明Visby Medical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。

K220407维斯比医疗性健康检测

官方来源

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