FDA 510(k)

服装电极

K号: K222863 · 2023-02-01

决定日期2023-02-01

产品代码GXY

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Garment Electrodes 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 2023-02-01 under 510(k) number K222863. 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 Garment Electrodes?

Garment Electrodes is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Tone-A-Matic International, Inc.. The 510(k) number is K222863.

When did Garment Electrodes receive FDA 510(k) clearance?

Garment Electrodes received FDA 510(k) clearance on 2023-02-01, under 510(k) number K222863.

Who is the listed applicant for Garment Electrodes?

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 Garment Electrodes?

The FDA product code for Garment Electrodes is GXY.

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。

K221724导电凝胶

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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