免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Revive可重复使用膀胱支撑

K号: K183468 · 2019-01-25

决定日期2019-01-25
产品代码HHW
咨询委员会OB 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Revive Reusable Bladder Support is the device name listed in this FDA 510(k) record. The listed applicant is Rinovum Subsidiary 2, LLC. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K183468. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Revive Reusable Bladder Support?

Revive Reusable Bladder Support is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Rinovum Subsidiary 2, LLC. The 510(k) number is K183468.

When did Revive Reusable Bladder Support receive FDA 510(k) clearance?

Revive Reusable Bladder Support received FDA 510(k) clearance on 2019-01-25, under 510(k) number K183468.

Who is the listed applicant for Revive Reusable Bladder Support?

The FDA 510(k) record lists Rinovum Subsidiary 2, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revive Reusable Bladder Support?

The FDA product code for Revive Reusable Bladder Support is HHW.

相关临床试验

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。

相关器械(代码:HHW)

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。

官方来源

在 FDA 数据库中查看 →

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。

↑