FDA 510(k)

Ceribell婴儿癫痫检测软件

K号: K252070 · 2025-11-21

决定日期2025-11-21

产品代码OMB

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决定实质等同

器械摘要

Ceribell Infant Seizure Detection Software is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K252070. 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 Infant Seizure Detection Software?

Ceribell Infant Seizure Detection Software is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Ceribell, Inc.. The 510(k) number is K252070.

When did Ceribell Infant Seizure Detection Software receive FDA 510(k) clearance?

Ceribell Infant Seizure Detection Software received FDA 510(k) clearance on 2025-11-21, under 510(k) number K252070.

Who is the listed applicant for Ceribell Infant Seizure Detection Software?

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 Infant Seizure Detection Software?

The FDA product code for Ceribell Infant Seizure Detection Software is OMB.

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。

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官方来源

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