NeurAxis IB-Stim (01-1020)
K号: K250451 · 2025-05-15
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申请人Neuraxis
决定日期2025-05-15
产品代码QHH
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
NeurAxis IB-Stim (01-1020) is the device name listed in this FDA 510(k) record. The listed applicant is Neuraxis. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K250451. The device is classified under product code QHH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NeurAxis IB-Stim (01-1020)?
NeurAxis IB-Stim (01-1020) is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Neuraxis. The 510(k) number is K250451.
When did NeurAxis IB-Stim (01-1020) receive FDA 510(k) clearance?
NeurAxis IB-Stim (01-1020) received FDA 510(k) clearance on 2025-05-15, under 510(k) number K250451.
Who is the listed applicant for NeurAxis IB-Stim (01-1020)?
The FDA 510(k) record lists Neuraxis as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeurAxis IB-Stim (01-1020)?
The FDA product code for NeurAxis IB-Stim (01-1020) is QHH.
相关临床试验
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列明Neuraxis为申报人的其他记录
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相关器械（代码：QHH）
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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