FDA 510(k)

Fast Warm - NX

K号: K250445 · 2025-09-12

决定日期2025-09-12

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

Fast Warm - NX is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K250445. 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 Fast Warm - NX?

Fast Warm - NX is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Fujifilm Irvine Scientific. The 510(k) number is K250445.

When did Fast Warm - NX receive FDA 510(k) clearance?

Fast Warm - NX received FDA 510(k) clearance on 2025-09-12, under 510(k) number K250445.

Who is the listed applicant for Fast Warm - NX?

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

What is the FDA product code for Fast Warm - NX?

The FDA product code for Fast Warm - NX is MQL.

列明Fujifilm Irvine Scientific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：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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