Ceribell癫痫持续状态监测器
K号: K223504 · 2023-05-23
广告
决定日期2023-05-23
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
Ceribell Status Epilepticus Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2023-05-23 under 510(k) number K223504. 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 Ceribell Status Epilepticus Monitor?
Ceribell Status Epilepticus Monitor is a medical device that received FDA 510(k) clearance on 2023-05-23. The listed applicant is Ceribell, Inc.. The 510(k) number is K223504.
When did Ceribell Status Epilepticus Monitor receive FDA 510(k) clearance?
Ceribell Status Epilepticus Monitor received FDA 510(k) clearance on 2023-05-23, under 510(k) number K223504.
Who is the listed applicant for Ceribell Status Epilepticus Monitor?
FDA 510(k)记录中列出Ceribell, Inc.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 Ceribell Status Epilepticus Monitor?
The FDA product code for Ceribell Status Epilepticus Monitor 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Ceribell, 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