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FDA 510(k)

IPG，集成，25/40 cm，单，带刺，IPG，2 cm，单4，铅（25/40 cm，4，带刺），延长线 - 4

K号: K191435 · 2019-09-06

申请人Nalu Medical, Inc.
决定日期2019-09-06
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

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 is the device name listed in this FDA 510(k) record. The listed applicant is Nalu Medical, Inc.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191435. 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 IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Nalu Medical, Inc.. The 510(k) number is K191435.

When did IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 receive FDA 510(k) clearance?

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191435.

Who is the listed applicant for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

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

What is the FDA product code for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

The FDA product code for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 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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