FDA 510(k)

日立医電 QP-160AK 脑电图趋势程序

K号: K163644 · 2017-05-19

决定日期2017-05-19

产品代码OMA

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决定实质等同

器械摘要

Nihon Kohden QP-160AK EEG Trend Program is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K163644. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nihon Kohden QP-160AK EEG Trend Program?

Nihon Kohden QP-160AK EEG Trend Program is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K163644.

When did Nihon Kohden QP-160AK EEG Trend Program receive FDA 510(k) clearance?

Nihon Kohden QP-160AK EEG Trend Program received FDA 510(k) clearance on 2017-05-19, under 510(k) number K163644.

Who is the listed applicant for Nihon Kohden QP-160AK EEG Trend Program?

FDA 510(k)记录中列出Nihon Kohden Corporation为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Nihon Kohden QP-160AK EEG Trend Program?

The FDA product code for Nihon Kohden QP-160AK EEG Trend Program is OMA.

列明Nihon Kohden Corporation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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