FDA 510(k)

SPY Phi 开放场手持式荧光成像系统

K号: K162885 · 2017-01-11

决定日期2017-01-11

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

SPY Phi Open Field Handheld Fluorescence Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies, Inc.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162885. 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 SPY Phi Open Field Handheld Fluorescence Imaging System?

SPY Phi Open Field Handheld Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Novadaq Technologies, Inc.. The 510(k) number is K162885.

When did SPY Phi Open Field Handheld Fluorescence Imaging System receive FDA 510(k) clearance?

SPY Phi Open Field Handheld Fluorescence Imaging System received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162885.

Who is the listed applicant for SPY Phi Open Field Handheld Fluorescence Imaging System?

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

What is the FDA product code for SPY Phi Open Field Handheld Fluorescence Imaging System?

The FDA product code for SPY Phi Open Field Handheld Fluorescence Imaging System is OWN.

列明Novadaq 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。

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官方来源

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