HomeSleepTest (HST, HST REM+)
K号: K240700 · 2024-12-08
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决定日期2024-12-08
产品代码OLV
咨询委员会NE
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决定实质等同
器械摘要
HomeSleepTest (HST, HST REM+) is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2024-12-08 under 510(k) number K240700. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HomeSleepTest (HST, HST REM+)?
HomeSleepTest (HST, HST REM+) is a medical device that received FDA 510(k) clearance on 2024-12-08. The listed applicant is Somnomedics GmbH. The 510(k) number is K240700.
When did HomeSleepTest (HST, HST REM+) receive FDA 510(k) clearance?
HomeSleepTest (HST, HST REM+) received FDA 510(k) clearance on 2024-12-08, under 510(k) number K240700.
Who is the listed applicant for HomeSleepTest (HST, HST REM+)?
The FDA 510(k) record lists Somnomedics GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HomeSleepTest (HST, HST REM+)?
The FDA product code for HomeSleepTest (HST, HST REM+) is OLV.
相关临床试验
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列明Somnomedics GmbH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：OLV）
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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