Nicolet EDX
K号: K243982 · 2025-01-22
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决定日期2025-01-22
产品代码GWF
咨询委员会NE
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器械摘要
Nicolet EDX is the device name listed in this FDA 510(k) record. The listed applicant is Natus Neurology Incorporated. It received FDA 510(k) clearance on 2025-01-22 under 510(k) number K243982. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Nicolet EDX?
Nicolet EDX is a medical device that received FDA 510(k) clearance on 2025-01-22. The listed applicant is Natus Neurology Incorporated. The 510(k) number is K243982.
When did Nicolet EDX receive FDA 510(k) clearance?
Nicolet EDX received FDA 510(k) clearance on 2025-01-22, under 510(k) number K243982.
Who is the listed applicant for Nicolet EDX?
The FDA 510(k) record lists Natus Neurology Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nicolet EDX?
The FDA product code for Nicolet EDX is GWF.
相关临床试验
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列明Natus Neurology Incorporated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：GWF）
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
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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