REMI 远程脑电图监测系统
K号: K243185 · 2025-03-21
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申请人Epitel
决定日期2025-03-21
产品代码OMC
咨询委员会NE
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决定实质等同
器械摘要
REMI Remote EEG Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Epitel. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K243185. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the REMI Remote EEG Monitoring System?
REMI Remote EEG Monitoring System is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Epitel. The 510(k) number is K243185.
When did REMI Remote EEG Monitoring System receive FDA 510(k) clearance?
REMI Remote EEG Monitoring System received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243185.
Who is the listed applicant for REMI Remote EEG Monitoring System?
The FDA 510(k) record lists Epitel as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for REMI Remote EEG Monitoring System?
The FDA product code for REMI Remote EEG Monitoring System is OMC.
相关临床试验
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相关器械（代码：OMC）
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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