RX-1 睡眠
K号: K253148 · 2026-06-22
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决定日期2026-06-22
产品代码MNR
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
RX-1 Sleep is the device name listed in this FDA 510(k) record. The listed applicant is Vivaquant, Inc. Dba Rhythm Express. It received FDA 510(k) clearance on 2026-06-22 under 510(k) number K253148. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RX-1 Sleep?
RX-1 Sleep is a medical device that received FDA 510(k) clearance on 2026-06-22. The listed applicant is Vivaquant, Inc. Dba Rhythm Express. The 510(k) number is K253148.
When did RX-1 Sleep receive FDA 510(k) clearance?
RX-1 Sleep received FDA 510(k) clearance on 2026-06-22, under 510(k) number K253148.
Who is the listed applicant for RX-1 Sleep?
The FDA 510(k) record lists Vivaquant, Inc. Dba Rhythm Express as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RX-1 Sleep?
The FDA product code for RX-1 Sleep is MNR.
相关临床试验
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相关器械（代码：MNR）
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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