ProSomnus EVO [PH] 睡眠和打鼾设备，带患者监测的 ProSomnus EVO [PH] 睡眠和打鼾设备
K号: K221889 · 2022-10-06
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器械摘要
常见问题
What is the ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Prosomnus Sleep Technologies. The 510(k) number is K221889.
When did ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring receive FDA 510(k) clearance?
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring received FDA 510(k) clearance on 2022-10-06, under 510(k) number K221889.
Who is the listed applicant for ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?
The FDA 510(k) record lists Prosomnus Sleep Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?
The FDA product code for ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is LRK.
相关临床试验
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列明Prosomnus Sleep Technologies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：LRK）
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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