FDA 510(k)

Ceribell谵妄监测系统

K号: K251936 · 2025-12-08

决定日期2025-12-08

产品代码NCG

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决定实质等同

器械摘要

Ceribell Delirium Monitor System is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2025-12-08 under 510(k) number K251936. The device is classified under product code NCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ceribell Delirium Monitor System?

Ceribell Delirium Monitor System is a medical device that received FDA 510(k) clearance on 2025-12-08. The listed applicant is Ceribell, Inc.. The 510(k) number is K251936.

When did Ceribell Delirium Monitor System receive FDA 510(k) clearance?

Ceribell Delirium Monitor System received FDA 510(k) clearance on 2025-12-08, under 510(k) number K251936.

Who is the listed applicant for Ceribell Delirium Monitor System?

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 Delirium Monitor System?

The FDA product code for Ceribell Delirium Monitor System is NCG.

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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