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FDA 510(k)

V-HEPES PLUS

K号: K213293 · 2022-09-14

决定日期2022-09-14
产品代码MQL
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

V-HEPES PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Vitromed Langenfeld. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K213293. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the V-HEPES PLUS?

V-HEPES PLUS is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Vitromed Langenfeld. The 510(k) number is K213293.

When did V-HEPES PLUS receive FDA 510(k) clearance?

V-HEPES PLUS received FDA 510(k) clearance on 2022-09-14, under 510(k) number K213293.

Who is the listed applicant for V-HEPES PLUS?

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

What is the FDA product code for V-HEPES PLUS?

The FDA product code for V-HEPES PLUS is MQL.

相关临床试验

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相关器械(代码:MQL)

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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