OCD MT Cap (85-00397-000)
K号: K231350 · 2023-06-08
广告
申请人Neuronetics
决定日期2023-06-08
产品代码QCI
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
OCD MT Cap (85-00397-000) is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K231350. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OCD MT Cap (85-00397-000)?
OCD MT Cap (85-00397-000) is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Neuronetics. The 510(k) number is K231350.
When did OCD MT Cap (85-00397-000) receive FDA 510(k) clearance?
OCD MT Cap (85-00397-000) received FDA 510(k) clearance on 2023-06-08, under 510(k) number K231350.
Who is the listed applicant for OCD MT Cap (85-00397-000)?
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 OCD MT Cap (85-00397-000)?
The FDA product code for OCD MT Cap (85-00397-000) is QCI.
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：QCI）
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。
K243459终极经颅磁刺激器（OCD）系列（M系列）Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge 用于强迫症Teleemg, LLCK221129CloudTMS 用于强迫症Teleemg, LLCK212289NeuroStar 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，NeuroStarNeuronetics, Inc.K193006MagVenture TMS治疗 - 用于治疗OCD，MagVenture TMS治疗系统Tonica Elektronik A/S
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。
广告