EEG-acp
K号: K212325 · 2022-06-15
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决定日期2022-06-15
产品代码GYB
咨询委员会NE
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决定实质等同
器械摘要
EEG-acp is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K212325. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EEG-acp?
EEG-acp is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is Somnomedics GmbH. The 510(k) number is K212325.
When did EEG-acp receive FDA 510(k) clearance?
EEG-acp received FDA 510(k) clearance on 2022-06-15, under 510(k) number K212325.
Who is the listed applicant for EEG-acp?
The FDA 510(k) record lists Somnomedics GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EEG-acp?
The FDA product code for EEG-acp is GYB.
列明Somnomedics GmbH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：GYB）
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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