FDA 510(k)

杜蕾斯Penck Standard，杜蕾斯Penck XL

K号: K200672 · 2020-11-06

决定日期2020-11-06

产品代码HIS

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决定实质等同

器械摘要

Durex Penck Standard, Durex Penck XL is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K200672. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Durex Penck Standard, Durex Penck XL?

Durex Penck Standard, Durex Penck XL is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K200672.

When did Durex Penck Standard, Durex Penck XL receive FDA 510(k) clearance?

Durex Penck Standard, Durex Penck XL received FDA 510(k) clearance on 2020-11-06, under 510(k) number K200672.

Who is the listed applicant for Durex Penck Standard, Durex Penck XL?

The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Durex Penck Standard, Durex Penck XL?

The FDA product code for Durex Penck Standard, Durex Penck XL is HIS.

列明Rb Health (Us), LLC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。

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相关器械（代码：HIS）

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。

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官方来源

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