FDA 510(k)

杜蕾斯Penck III Regular

K号: K222068 · 2022-10-12

决定日期2022-10-12

产品代码HIS

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决定实质等同

器械摘要

Durex Penck III Regular 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 2022-10-12 under 510(k) number K222068. 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 III Regular?

Durex Penck III Regular is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K222068.

When did Durex Penck III Regular receive FDA 510(k) clearance?

Durex Penck III Regular received FDA 510(k) clearance on 2022-10-12, under 510(k) number K222068.

Who is the listed applicant for Durex Penck III Regular?

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 III Regular?

The FDA product code for Durex Penck III Regular 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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