Neuroblade 系统
K号: K230125 · 2023-10-13
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决定日期2023-10-13
产品代码GWG
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。
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器械摘要
Neuroblade System is the device name listed in this FDA 510(k) record. The listed applicant is Clearmind Biomedical. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K230125. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Neuroblade System?
Neuroblade System is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Clearmind Biomedical. The 510(k) number is K230125.
When did Neuroblade System receive FDA 510(k) clearance?
Neuroblade System received FDA 510(k) clearance on 2023-10-13, under 510(k) number K230125.
Who is the listed applicant for Neuroblade System?
The FDA 510(k) record lists Clearmind Biomedical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Neuroblade System?
The FDA product code for Neuroblade System is GWG.
相关临床试验
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列明Clearmind Biomedical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：GWG）
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。
K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro 灌洗系统Stryker InstrumentsK243429HJY VisualNext 3D 内窥镜视觉系统Hjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® 系统（ASX15/60）；AURORA® Surgiscope® 系统（ASX15/80）Integra LifeSciences CorporationK233391cCeLL - 在体VPIX Medical, Inc.K223615数字ClarusScope系统，数字NeuroPEN系统Clarus Medical, LLC
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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