NEAT 001
K号: K250058 · 2025-04-10
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决定日期2025-04-10
产品代码OLZ
咨询委员会NE
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器械摘要
NEAT 001 is the device name listed in this FDA 510(k) record. The listed applicant is Brain Electrophysiology Laboratory Company, LLC. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250058. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NEAT 001?
NEAT 001 is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Brain Electrophysiology Laboratory Company, LLC. The 510(k) number is K250058.
When did NEAT 001 receive FDA 510(k) clearance?
NEAT 001 received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250058.
Who is the listed applicant for NEAT 001?
The FDA 510(k) record lists Brain Electrophysiology Laboratory Company, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NEAT 001?
The FDA product code for NEAT 001 is OLZ.
列明Brain Electrophysiology Laboratory Company, LLC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：OLZ）
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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