终极经颅磁刺激器；盈驰经颅磁刺激器
K号: K230735 · 2023-09-13
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决定日期2023-09-13
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
Ultimate rTMS; Yingchi rTMS is the device name listed in this FDA 510(k) record. The listed applicant is Brain Ultimate, Inc.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K230735. 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 Ultimate rTMS; Yingchi rTMS?
Ultimate rTMS; Yingchi rTMS is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is Brain Ultimate, Inc.. The 510(k) number is K230735.
When did Ultimate rTMS; Yingchi rTMS receive FDA 510(k) clearance?
Ultimate rTMS; Yingchi rTMS received FDA 510(k) clearance on 2023-09-13, under 510(k) number K230735.
Who is the listed applicant for Ultimate rTMS; Yingchi rTMS?
FDA 510(k)记录显示，Brain Ultimate, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Ultimate rTMS; Yingchi rTMS?
The FDA product code for Ultimate rTMS; Yingchi rTMS 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Brain Ultimate, 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。
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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