FDA 510(k)

导电凝胶

K号: K221724 · 2022-09-23

决定日期2022-09-23

产品代码GYB

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决定实质等同

器械摘要

Conductive Gel is the device name listed in this FDA 510(k) record. The listed applicant is Tone-A-Matic International, Inc.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K221724. 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 Conductive Gel?

Conductive Gel is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Tone-A-Matic International, Inc.. The 510(k) number is K221724.

When did Conductive Gel receive FDA 510(k) clearance?

Conductive Gel received FDA 510(k) clearance on 2022-09-23, under 510(k) number K221724.

Who is the listed applicant for Conductive Gel?

The FDA 510(k) record lists Tone-A-Matic International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Conductive Gel?

The FDA product code for Conductive Gel is GYB.

列明Tone-A-Matic International, Inc.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。

K222863服装电极

官方来源

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