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FDA 510(k)

DMRX 100ml空容器溶液;DMRX 250ml空容器溶液;DMRX 500ml空容器溶液;DMRX 1000ml空容器溶液

K号: K250459 · 2025-04-18

决定日期2025-04-18
产品代码KPE
咨询委员会医疗设备监管文本翻译如下: HO 请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution is the device name listed in this FDA 510(k) record. The listed applicant is Technoflex Sas.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K250459. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution?

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Technoflex Sas.. The 510(k) number is K250459.

When did DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution receive FDA 510(k) clearance?

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution received FDA 510(k) clearance on 2025-04-18, under 510(k) number K250459.

Who is the listed applicant for DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution?

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

What is the FDA product code for DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution?

The FDA product code for DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution is KPE.

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:KPE)

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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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。

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