FDA 510(k)

AC 涂膏 - 导电膏

K号: K212326 · 2021-12-01

决定日期2021-12-01

产品代码GYB

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决定实质等同

器械摘要

AC Cream - Conductive paste 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 2021-12-01 under 510(k) number K212326. 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 AC Cream - Conductive paste?

AC Cream - Conductive paste is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Spes Medica Srl. The 510(k) number is K212326.

When did AC Cream - Conductive paste receive FDA 510(k) clearance?

AC Cream - Conductive paste received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212326.

Who is the listed applicant for AC Cream - Conductive paste?

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 AC Cream - Conductive paste?

The FDA product code for AC Cream - Conductive paste 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 K192606SAC2 - 电极膏 K192603Spes Medica 皮下针电极 K190050Tech Dots - Adhesive and conductive gel

官方来源

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