NEBA® Compact EEG2R移动头戴式耳机
K号: K223628 · 2023-03-02
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决定日期2023-03-02
产品代码OMC
咨询委员会NE
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器械摘要
NEBA® Compact EEG2R Mobile Headset is the device name listed in this FDA 510(k) record. The listed applicant is Neba Health, LLC. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223628. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NEBA® Compact EEG2R Mobile Headset?
NEBA® Compact EEG2R Mobile Headset is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Neba Health, LLC. The 510(k) number is K223628.
When did NEBA® Compact EEG2R Mobile Headset receive FDA 510(k) clearance?
NEBA® Compact EEG2R Mobile Headset received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223628.
Who is the listed applicant for NEBA® Compact EEG2R Mobile Headset?
The FDA 510(k) record lists Neba Health, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NEBA® Compact EEG2R Mobile Headset?
The FDA product code for NEBA® Compact EEG2R Mobile Headset is OMC.
相关临床试验
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相关器械（代码：OMC）
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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