FDA 510(k)

GT5 conductive & abrasive gel

K号: K212787 · 2021-11-08

决定日期2021-11-08

产品代码GYB

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决定实质等同

器械摘要

GT5 conductive & abrasive gel 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 2021-11-08 under 510(k) number K212787. 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 GT5 conductive & abrasive gel?

GT5 conductive & abrasive gel is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Wuhan Greentek Pty , Ltd.. The 510(k) number is K212787.

When did GT5 conductive & abrasive gel receive FDA 510(k) clearance?

GT5 conductive & abrasive gel received FDA 510(k) clearance on 2021-11-08, under 510(k) number K212787.

Who is the listed applicant for GT5 conductive & abrasive gel?

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 GT5 conductive & abrasive gel?

The FDA product code for GT5 conductive & abrasive gel is GYB.

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。

K200162一次性脑电图电极（型号：DL，E-CAP，FLEX-CAP）

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