FDA 510(k)

Elefix V Paste for EEG & EMG

K号: K191975 · 2020-02-07

决定日期2020-02-07

产品代码GYB

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决定实质等同

器械摘要

Elefix V Paste for EEG & EMG 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 2020-02-07 under 510(k) number K191975. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elefix V Paste for EEG & EMG?

Elefix V Paste for EEG & EMG is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K191975.

When did Elefix V Paste for EEG & EMG receive FDA 510(k) clearance?

Elefix V Paste for EEG & EMG received FDA 510(k) clearance on 2020-02-07, under 510(k) number K191975.

Who is the listed applicant for Elefix V Paste for EEG & EMG?

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 Elefix V Paste for EEG & EMG?

The FDA product code for Elefix V Paste for EEG & EMG is GYB.

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。

K251641GF-310R 多气体单元（GF-310R）K260747YP-710T系列血压计袖带；YP-840T系列一次性袖带 K251366EEG-1260A Neurofax系统（EEG-1260A）；JE-940A EEG放大器单元（JE-940A）；LS-940A光刺激器（LS-940A）K243956TG-980P CO2 传感器套件 (TG-980P); TG-980P1 CO2 传感器套件 (TG-980P1)K223567CNS-2101 中央监测仪 K220976Life Scope PT BSM-1700系列床旁监护仪

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官方来源

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