NeuroStar 高级治疗系统（版本 3.7）
K号: K230029 · 2023-04-04
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申请人Neuronetics
决定日期2023-04-04
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 Advanced Therapy System (Version 3.7) is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics. It received FDA 510(k) clearance on 2023-04-04 under 510(k) number K230029. 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 Advanced Therapy System (Version 3.7)?
NeuroStar Advanced Therapy System (Version 3.7) is a medical device that received FDA 510(k) clearance on 2023-04-04. The listed applicant is Neuronetics. The 510(k) number is K230029.
When did NeuroStar Advanced Therapy System (Version 3.7) receive FDA 510(k) clearance?
NeuroStar Advanced Therapy System (Version 3.7) received FDA 510(k) clearance on 2023-04-04, under 510(k) number K230029.
Who is the listed applicant for NeuroStar Advanced Therapy System (Version 3.7)?
The FDA 510(k) record lists Neuronetics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeuroStar Advanced Therapy System (Version 3.7)?
The FDA product code for NeuroStar Advanced Therapy System (Version 3.7) 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。
列明Neuronetics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。
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
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。
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