SleepStageML
K号: K233438 · 2024-03-08
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决定日期2024-03-08
产品代码OLZ
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
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器械摘要
SleepStageML is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Biosignals, Inc.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K233438. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SleepStageML?
SleepStageML is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Beacon Biosignals, Inc.. The 510(k) number is K233438.
When did SleepStageML receive FDA 510(k) clearance?
SleepStageML received FDA 510(k) clearance on 2024-03-08, under 510(k) number K233438.
Who is the listed applicant for SleepStageML?
FDA 510(k)记录将Beacon Biosignals, Inc.列为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for SleepStageML?
The FDA product code for SleepStageML is OLZ.
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Beacon Biosignals, Inc.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：OLZ）
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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