REMI AI 离散检测模块
K号: K231779 · 2024-01-03
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申请人Epitel, Inc.
决定日期2024-01-03
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 Discrete Detection Module is the device name listed in this FDA 510(k) record. The listed applicant is Epitel, Inc.. It received FDA 510(k) clearance on 2024-01-03 under 510(k) number K231779. 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 Discrete Detection Module?
REMI AI Discrete Detection Module is a medical device that received FDA 510(k) clearance on 2024-01-03. The listed applicant is Epitel, Inc.. The 510(k) number is K231779.
When did REMI AI Discrete Detection Module receive FDA 510(k) clearance?
REMI AI Discrete Detection Module received FDA 510(k) clearance on 2024-01-03, under 510(k) number K231779.
Who is the listed applicant for REMI AI Discrete Detection Module?
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 Discrete Detection Module?
The FDA product code for REMI AI Discrete Detection Module 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。
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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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