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FDA 510(k)

FlexStim 神经刺激电极型号:5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W

K号: K161282 · 2016-10-30

决定日期2016-10-30
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

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W is the device name listed in this FDA 510(k) record. The listed applicant is Medico Electrodes International , Ltd.. It received FDA 510(k) clearance on 2016-10-30 under 510(k) number K161282. 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 FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W?

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W is a medical device that received FDA 510(k) clearance on 2016-10-30. The listed applicant is Medico Electrodes International , Ltd.. The 510(k) number is K161282.

When did FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W receive FDA 510(k) clearance?

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W received FDA 510(k) clearance on 2016-10-30, under 510(k) number K161282.

Who is the listed applicant for FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W?

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

What is the FDA product code for FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W?

The FDA product code for FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W is GXY.

相关临床试验

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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。

官方来源

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