FDA 510(k)

Tech Dots - Adhesive and conductive gel

K号: K190050 · 2019-07-19

决定日期2019-07-19

产品代码GYB

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决定实质等同

器械摘要

Tech Dots - Adhesive and conductive gel is the device name listed in this FDA 510(k) record. The listed applicant is Spes Medica Srl. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K190050. 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 Tech Dots - Adhesive and conductive gel?

Tech Dots - Adhesive and conductive gel is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Spes Medica Srl. The 510(k) number is K190050.

When did Tech Dots - Adhesive and conductive gel receive FDA 510(k) clearance?

Tech Dots - Adhesive and conductive gel received FDA 510(k) clearance on 2019-07-19, under 510(k) number K190050.

Who is the listed applicant for Tech Dots - Adhesive and conductive gel?

The FDA 510(k) record lists Spes Medica Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tech Dots - Adhesive and conductive gel?

The FDA product code for Tech Dots - Adhesive and conductive gel is GYB.

列明Spes Medica Srl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。

K211954硬脑膜电极，条带/术中条带，网格/术中网格，多条带和分裂网格，术中映射网格 K212326AC 涂膏 - 导电膏 K192606SAC2 - 电极膏 K192603Spes Medica 皮下针电极

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