FDA 510(k)

Tutamen自粘电极

K号: K252439 · 2026-05-01

决定日期2026-05-01

产品代码GXY

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决定实质等同

器械摘要

Tutamen Self Adhesive Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Tutamen Metalwork Co., Ltd.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K252439. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tutamen Self Adhesive Electrodes?

Tutamen Self Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Dongguan Tutamen Metalwork Co., Ltd.. The 510(k) number is K252439.

When did Tutamen Self Adhesive Electrodes receive FDA 510(k) clearance?

Tutamen Self Adhesive Electrodes received FDA 510(k) clearance on 2026-05-01, under 510(k) number K252439.

Who is the listed applicant for Tutamen Self Adhesive Electrodes?

The FDA 510(k) record lists Dongguan Tutamen Metalwork Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tutamen Self Adhesive Electrodes?

The FDA product code for Tutamen Self Adhesive Electrodes is GXY.

列明Dongguan Tutamen Metalwork Co., 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。

K240472PBM 毛发治疗帽

相关器械（代码：GXY）

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。

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