FDA 510(k)

一次性脑电图电极（型号：DL，E-CAP，FLEX-CAP）

K号: K200162 · 2020-04-21

决定日期2020-04-21

产品代码GXY

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决定实质等同

器械摘要

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Greentek Pty , Ltd.. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K200162. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Wuhan Greentek Pty , Ltd.. The 510(k) number is K200162.

When did Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) receive FDA 510(k) clearance?

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) received FDA 510(k) clearance on 2020-04-21, under 510(k) number K200162.

Who is the listed applicant for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

The FDA 510(k) record lists Wuhan Greentek Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)?

The FDA product code for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is GXY.

列明Wuhan Greentek Pty , Ltd.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。

K212787GT5 conductive & abrasive gel

相关器械（代码：GXY）

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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