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FDA 510(k)

NeuroStar，NeuroStar TMS 治疗系统，NeuroStar 高级治疗系统，NeuroStar 高级治疗系统用于心理健康

K号: K222230 · 2022-08-24

申请人Neuronetics, Inc.
决定日期2022-08-24
产品代码OBP
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

NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2022-08-24 under 510(k) number K222230. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health?

NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Neuronetics, Inc.. The 510(k) number is K222230.

When did NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health receive FDA 510(k) clearance?

NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health received FDA 510(k) clearance on 2022-08-24, under 510(k) number K222230.

Who is the listed applicant for NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health?

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

What is the FDA product code for NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health?

The FDA product code for NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health is OBP.

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

列明Neuronetics, Inc.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。

K231926NeuroStar 高级治疗系统（所有先前已批准的型号）K220127NeuroStar TMS 治疗系统，NeuroStar 高级治疗系统，NeuroStar，NeuroStar 高级治疗用于心理健康K212289NeuroStar 高级治疗用于强迫症的辅助治疗，NeuroStar 高级治疗系统，NeuroStar TMS 治疗系统，NeuroStar 高级治疗用于心理健康，NeuroStarK213543NeuroStar TMS 治疗系统，NeuroStar 高级治疗系统，NeuroStar，NeuroStar 高级治疗用于心理健康K201158NeuroStar 高级治疗K161519NeuroStar TMS 治疗系统

查看所有 8 个设备 →

相关器械（代码：OBP）

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。

K260396KCS rTMS治疗系统（经颅磁刺激器）（MetaStim 100，MetaStim 100A）Fidelity BioPharma Co.K260691BTL-699BTL Industries, Inc.K261228QuickVision Ultimate 经颅磁刺激器Brain Ultimate, Inc.K260189MagVenture加速TMS（aTMS）治疗系统Tonica Elektronik A/SK260560Apollo TMS 疗法系统；Apollo light TMS 疗法系统Mag & More GmbHK253098Nexstim 导航脑刺激 (NBS) 6 系统 (NBS6)Nexstim Oyj

官方来源

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