Sleepiz One+ (2.5)
K号: K251364 · 2025-07-29
广告
器械摘要
Sleepiz One+ (2.5) is the device name listed in this FDA 510(k) record. The listed applicant is Sleepiz AG. It received FDA 510(k) clearance on 2025-07-29 under 510(k) number K251364. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sleepiz One+ (2.5)?
Sleepiz One+ (2.5) is a medical device that received FDA 510(k) clearance on 2025-07-29. The listed applicant is Sleepiz AG. The 510(k) number is K251364.
When did Sleepiz One+ (2.5) receive FDA 510(k) clearance?
Sleepiz One+ (2.5) received FDA 510(k) clearance on 2025-07-29, under 510(k) number K251364.
Who is the listed applicant for Sleepiz One+ (2.5)?
The FDA 510(k) record lists Sleepiz AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sleepiz One+ (2.5)?
The FDA product code for Sleepiz One+ (2.5) is DRT.
相关临床试验
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。
列明Sleepiz AG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：DRT）
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。
K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286Circadia C300 系统（C300）Circadia Health, Inc.K252676Circadia C300 系统（C300）Circadia Health, Inc.K253388Sleepiz One+ (型号 2.5)Sleepiz AGK234003Circadia C200 系统Circadia Technologies, Ltd.K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.
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。
广告