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FDA 510(k)

Dixi Medical 手术室下脑膜电极（条带和网格）

K号: K201931 · 2021-10-02

申请人Dixi Medical
决定日期2021-10-02
产品代码GYC
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

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is the device name listed in this FDA 510(k) record. The listed applicant is Dixi Medical. It received FDA 510(k) clearance on 2021-10-02 under 510(k) number K201931. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is a medical device that received FDA 510(k) clearance on 2021-10-02. The listed applicant is Dixi Medical. The 510(k) number is K201931.

When did Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) receive FDA 510(k) clearance?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) received FDA 510(k) clearance on 2021-10-02, under 510(k) number K201931.

Who is the listed applicant for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

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

What is the FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

The FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is GYC.

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Dixi Medical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。

K202087DIXI 医疗微深微-宏观深度电极K170959DIXI 医疗微深电极

相关器械（代码：GYC）

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。

K250094Atlas 刺激头盒 (NK) (31-0601-0077)；Atlas 刺激头盒 (防触电) (31-0601-0089)；Atlas 刺激头盒 (HD) (31-0601-0132)；ASHB 光纤双工连接器 2m (31-0204-0001)；ASHB 光纤双工连接器 7m (31-0204-0002)；ATLAS 刺激头盒软件 (36-0301-0006)；Atlas 头盒接口电缆 (NK) (31-0204-003)；Atlas 头盒接口电缆 (防触电) (31-0204-004)；Atlas 头盒接口电缆 (HD) (31-0204-005)；Atlas 头盒扩展面板 (31-0607-0014)Neuralynx, Inc.K242618Layer 7-TPrecision Neuroscience, Corp.K221123智慧皮层条（WCS）Wise S.R.L.K211954硬脑膜电极，条带/术中条带，网格/术中网格，多条带和分裂网格，术中映射网格Spes Medica SrlK191346Blackrock NeuroCoG 颅下皮质电极（条带和网格）Blackrock MicrosystemsK191186硬脑膜条带/术中分裂电极，硬脑膜网格/术中网格电极，双侧半球间硬脑膜电极，多条带和裂隙网格硬脑膜电极，术中映射网格硬脑膜电极Ad-Tech Medical Instrument Corporation

官方来源

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