FDA 510(k)

SAC2 - 电极膏

K号: K192606 · 2020-01-17

决定日期2020-01-17

产品代码GYB

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决定实质等同

器械摘要

SAC2 - Electrode Cream 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 2020-01-17 under 510(k) number K192606. 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 SAC2 - Electrode Cream?

SAC2 - Electrode Cream is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Spes Medica Srl. The 510(k) number is K192606.

When did SAC2 - Electrode Cream receive FDA 510(k) clearance?

SAC2 - Electrode Cream received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192606.

Who is the listed applicant for SAC2 - Electrode Cream?

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 SAC2 - Electrode Cream?

The FDA product code for SAC2 - Electrode Cream 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 K192603Spes Medica 皮下针电极 K190050Tech Dots - Adhesive and conductive gel

官方来源

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