RED
K号: K242304 · 2024-12-06
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决定日期2024-12-06
产品代码KLA
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
RED is the device name listed in this FDA 510(k) record. The listed applicant is Neuraxis, Inc.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K242304. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RED?
RED is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Neuraxis, Inc.. The 510(k) number is K242304.
When did RED receive FDA 510(k) clearance?
RED received FDA 510(k) clearance on 2024-12-06, under 510(k) number K242304.
Who is the listed applicant for RED?
The FDA 510(k) record lists Neuraxis, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RED?
The FDA product code for RED is KLA.
相关 PubMed 文献
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。
PMID：42524332基于大型语言模型运动和健康指导的风险管理：针对健康到SaMD连续体的以中国为基点、比较信息化的六维触发矩阵和生命周期治理框架。Risk management and healthcare policy ()PMID：42299919泌尿科中的人工智能：美国食品药品监督管理局（FDA）批准的设备的综述。BJU international ()PMID：42397807借鉴癌症治疗策略：针对共享病理生物学的难以愈合伤口治疗的权威协议篮子试验。Journal of wound care ()PMID：42173550癌症护理中基于功能的SaMD设计监管基准研究BMJ health & care informatics ()
相关器械（代码：KLA）
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。
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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