SleepRes PAP系统
K号: K251770 · 2025-12-15
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决定日期2025-12-15
产品代码BZD
咨询委员会AN
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器械摘要
SleepRes PAP System is the device name listed in this FDA 510(k) record. The listed applicant is Sleepres, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K251770. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SleepRes PAP System?
SleepRes PAP System is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Sleepres, Inc.. The 510(k) number is K251770.
When did SleepRes PAP System receive FDA 510(k) clearance?
SleepRes PAP System received FDA 510(k) clearance on 2025-12-15, under 510(k) number K251770.
Who is the listed applicant for SleepRes PAP System?
The FDA 510(k) record lists Sleepres, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SleepRes PAP System?
The FDA product code for SleepRes PAP System is BZD.
相关临床试验
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相关器械（代码：BZD）
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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