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FDA 510(k)

RecoveryRx

K号: K190251 · 2019-06-28

决定日期2019-06-28
产品代码ILX
咨询委员会PM 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

RecoveryRx is the device name listed in this FDA 510(k) record. The listed applicant is Bioelectronics Corporation. It received FDA 510(k) clearance on 2019-06-28 under 510(k) number K190251. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RecoveryRx?

RecoveryRx is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Bioelectronics Corporation. The 510(k) number is K190251.

When did RecoveryRx receive FDA 510(k) clearance?

RecoveryRx received FDA 510(k) clearance on 2019-06-28, under 510(k) number K190251.

Who is the listed applicant for RecoveryRx?

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

What is the FDA product code for RecoveryRx?

The FDA product code for RecoveryRx is ILX.

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。

列明Bioelectronics Corporation为申报人的其他记录

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相关器械(代码:ILX)

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

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