FDA 510(k)

带夹子的电极/带尾线的电极

K号: K171722 · 2018-01-10

决定日期2018-01-10

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

Electrodes with snap / Electrodes with pigtail is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-10 under 510(k) number K171722. 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 Electrodes with snap / Electrodes with pigtail?

Electrodes with snap / Electrodes with pigtail is a medical device that received FDA 510(k) clearance on 2018-01-10. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K171722.

When did Electrodes with snap / Electrodes with pigtail receive FDA 510(k) clearance?

Electrodes with snap / Electrodes with pigtail received FDA 510(k) clearance on 2018-01-10, under 510(k) number K171722.

Who is the listed applicant for Electrodes with snap / Electrodes with pigtail?

The FDA 510(k) record lists Shenzhen Konmed Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrodes with snap / Electrodes with pigtail?

The FDA product code for Electrodes with snap / Electrodes with pigtail is GXY.

列明Shenzhen Konmed Technology 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。

K260178盆底肌肉训练器（KM510，KM516B）K233576Konmed 尿失禁刺激电极（阴道探头：KM-503，KM-504，KM-505，KM-506，KM-507，KM-5013；直肠探头：KM-502，KM-5018）K220161生物反馈神经肌肉刺激器 K202648生物反馈神经肌肉刺激器 K163288Pelvifine盆底肌肉训练器 K171721银导电电极

查看所有 7 个设备 →

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。

K262654Dexus假肢系统（MSL2，MSR2）Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM 杯 MRI/CT（型号 72704/21US，72704/23US，72704/25US，72704/27US）Ambu® NeurolineTM 杯 MRI/CT套装（型号 72704/21-1010US，72704/21-1010US，72704/23-1010US，72704/25-1010US，72704/27-1010US）Ambu® NeurolineTM 杯 MRI/CT迷你套装（型号 72704/21-0301US，72704/23-0301US，72704/25-0301US，72704/27-0301US）Ambu A/S K261442Charlotte ACC25 表面电极阵列；Charlotte ACC25 可重复使用表面电极阵列Cadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde 医疗电极（T5/ 5cm x 5cm 电极 T10/ 5cm x 10cm 电极）Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR 条件杯电极Technomed Europe

官方来源

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