CAIs 传感器（CAIs-001）
K号: K241160 · 2024-12-13
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决定日期2024-12-13
产品代码GXY
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
CAIs Sensor (CAIs-001) is the device name listed in this FDA 510(k) record. The listed applicant is Brainu Co., Ltd.. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K241160. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CAIs Sensor (CAIs-001)?
CAIs Sensor (CAIs-001) is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Brainu Co., Ltd.. The 510(k) number is K241160.
When did CAIs Sensor (CAIs-001) receive FDA 510(k) clearance?
CAIs Sensor (CAIs-001) received FDA 510(k) clearance on 2024-12-13, under 510(k) number K241160.
Who is the listed applicant for CAIs Sensor (CAIs-001)?
The FDA 510(k) record lists Brainu Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CAIs Sensor (CAIs-001)?
The FDA product code for CAIs Sensor (CAIs-001) is GXY.
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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：GXY）
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
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