FDA 510(k)

EPX-4440FN 数字视频处理器带光源

K号: K180414 · 2018-05-24

申请人Fujifilm New Development U.S.A., Inc.

决定日期2018-05-24

产品代码FET

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

EPX-4440FN Digital Video Processor with Light Source is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm New Development U.S.A., Inc.. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K180414. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EPX-4440FN Digital Video Processor with Light Source?

EPX-4440FN Digital Video Processor with Light Source is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Fujifilm New Development U.S.A., Inc.. The 510(k) number is K180414.

When did EPX-4440FN Digital Video Processor with Light Source receive FDA 510(k) clearance?

EPX-4440FN Digital Video Processor with Light Source received FDA 510(k) clearance on 2018-05-24, under 510(k) number K180414.

Who is the listed applicant for EPX-4440FN Digital Video Processor with Light Source?

The FDA 510(k) record lists Fujifilm New Development U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPX-4440FN Digital Video Processor with Light Source?

The FDA product code for EPX-4440FN Digital Video Processor with Light Source is FET.

列明Fujifilm New Development U.S.A., Inc.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。

K162836富士胶片外科手术系统 K170084InterLock 套管

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。