Modius 睡眠
K号: K230826 · 2023-10-27
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决定日期2023-10-27
产品代码QJQ
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
Modius Sleep is the device name listed in this FDA 510(k) record. The listed applicant is Neurovalens , Ltd.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K230826. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Modius Sleep?
Modius Sleep is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Neurovalens , Ltd.. The 510(k) number is K230826.
When did Modius Sleep receive FDA 510(k) clearance?
Modius Sleep received FDA 510(k) clearance on 2023-10-27, under 510(k) number K230826.
Who is the listed applicant for Modius Sleep?
The FDA 510(k) record lists Neurovalens , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Modius Sleep?
The FDA product code for Modius Sleep is QJQ.
相关临床试验
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相关器械（代码：QJQ）
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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