FDA 510(k)

MR 条件粘性垫电极

K号: K203079 · 2021-02-09

决定日期2021-02-09

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

MR Conditional Sticky Pad Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2021-02-09 under 510(k) number K203079. 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 MR Conditional Sticky Pad Electrode?

MR Conditional Sticky Pad Electrode is a medical device that received FDA 510(k) clearance on 2021-02-09. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K203079.

When did MR Conditional Sticky Pad Electrode receive FDA 510(k) clearance?

MR Conditional Sticky Pad Electrode received FDA 510(k) clearance on 2021-02-09, under 510(k) number K203079.

Who is the listed applicant for MR Conditional Sticky Pad Electrode?

The FDA 510(k) record lists Rhythmlink International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR Conditional Sticky Pad Electrode?

The FDA product code for MR Conditional Sticky Pad Electrode is GXY.

列明Rhythmlink International, LLC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。

K200984Guardian Needle Electrode K191225EEG预测和tDCS在纤维肌痛中的临床疗效 K190801PressOn电极耳机 K172503MR 条件杯电极，MR 条件Webb电极

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。