iNAP One睡眠治疗系统。
K号: K193460 · 2020-05-26
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决定日期2020-05-26
产品代码OZR
咨询委员会DE
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决定实质等同
器械摘要
The iNAP One Sleep Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Somnice, Inc.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K193460. The device is classified under product code OZR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the The iNAP One Sleep Therapy System?
The iNAP One Sleep Therapy System is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Somnice, Inc.. The 510(k) number is K193460.
When did The iNAP One Sleep Therapy System receive FDA 510(k) clearance?
The iNAP One Sleep Therapy System received FDA 510(k) clearance on 2020-05-26, under 510(k) number K193460.
Who is the listed applicant for The iNAP One Sleep Therapy System?
The FDA 510(k) record lists Somnice, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The iNAP One Sleep Therapy System?
The FDA product code for The iNAP One Sleep Therapy System is OZR.
相关临床试验
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相关器械（代码：OZR）
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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