REMI-AI 快速检测模块（REMI-AI RDM）
K号: K240408 · 2024-10-17
广告
申请人Epitel, Inc.
决定日期2024-10-17
产品代码OMB
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。
决定实质等同
器械摘要
REMI-AI Rapid Detection Module (REMI-AI RDM) is the device name listed in this FDA 510(k) record. The listed applicant is Epitel, Inc.. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K240408. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the REMI-AI Rapid Detection Module (REMI-AI RDM)?
REMI-AI Rapid Detection Module (REMI-AI RDM) is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Epitel, Inc.. The 510(k) number is K240408.
When did REMI-AI Rapid Detection Module (REMI-AI RDM) receive FDA 510(k) clearance?
REMI-AI Rapid Detection Module (REMI-AI RDM) received FDA 510(k) clearance on 2024-10-17, under 510(k) number K240408.
Who is the listed applicant for REMI-AI Rapid Detection Module (REMI-AI RDM)?
The FDA 510(k) record lists Epitel, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for REMI-AI Rapid Detection Module (REMI-AI RDM)?
The FDA product code for REMI-AI Rapid Detection Module (REMI-AI RDM) is OMB.
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Epitel, 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：OMB）
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。
K260998Ceribell神经病学审查软件Ceribell, Inc.K252070Ceribell婴儿癫痫检测软件Ceribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK243743autoSCORE（V 2.0.0）Holberg Eeg ASK241589Ceribell癫痫发作检测软件Ceribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation
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