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FDA 510(k)

刺激器，刺激器套件，外部发射器，外部发射器套件

K号: K200848 · 2020-08-14

申请人Micron Medical Corporation
决定日期2020-08-14
产品代码GZF
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

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit is the device name listed in this FDA 510(k) record. The listed applicant is Micron Medical Corporation. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K200848. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit?

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Micron Medical Corporation. The 510(k) number is K200848.

When did Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit receive FDA 510(k) clearance?

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit received FDA 510(k) clearance on 2020-08-14, under 510(k) number K200848.

Who is the listed applicant for Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit?

The FDA 510(k) record lists Micron Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit?

The FDA product code for Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit is GZF.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：GZF）

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。

K253877StimTrial 神经调节系统Bioventus, LLCK243782StimTrial 神经调节系统Bioventus, LLCK243678TalisMann 神经调节系统Bioventus, LLCK232415Nalu神经刺激系统用于周围神经刺激Boston Scientific NeuromodulationK233162Freedom周围神经刺激器（PNS）系统CuronixK221303Neuspera Nuity 系统Neuspera Medical, Inc.

官方来源

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