FDA 510(k)

FloNavi 开放场荧光成像系统

K号: K230407 · 2023-07-17

申请人Guangdong Optomedic Technologies, Inc.

决定日期2023-07-17

产品代码OWN

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

FloNavi Open Field Fluorescence Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230407. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FloNavi Open Field Fluorescence Imaging System?

FloNavi Open Field Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K230407.

When did FloNavi Open Field Fluorescence Imaging System receive FDA 510(k) clearance?

FloNavi Open Field Fluorescence Imaging System received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230407.

Who is the listed applicant for FloNavi Open Field Fluorescence Imaging System?

The FDA 510(k) record lists Guangdong Optomedic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FloNavi Open Field Fluorescence Imaging System?

The FDA product code for FloNavi Open Field Fluorescence Imaging System is OWN.

列明Guangdong Optomedic Technologies, 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。

K252318充气器（OPTO-IFL1000）K2526973D 腹腔镜 K242513FloNavi 内窥镜荧光成像系统（OPTO-CAM214K，OPTO-CHD214KE，OPTOCHD214KH，OPTO-LED214K）K241530Stellar 成像系统 K231342充气器（OPTO-IFL1000）K231003腹腔镜（21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC）

查看所有 9 个设备 →

官方来源

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