AirRay硬脑膜皮层电极
K号: K183437 · 2019-03-12
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申请人Cortec GmbH
决定日期2019-03-12
产品代码GYC
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
AirRay Subdural Cortical Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Cortec GmbH. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183437. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AirRay Subdural Cortical Electrodes?
AirRay Subdural Cortical Electrodes is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Cortec GmbH. The 510(k) number is K183437.
When did AirRay Subdural Cortical Electrodes receive FDA 510(k) clearance?
AirRay Subdural Cortical Electrodes received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183437.
Who is the listed applicant for AirRay Subdural Cortical Electrodes?
The FDA 510(k) record lists Cortec GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirRay Subdural Cortical Electrodes?
The FDA product code for AirRay Subdural Cortical Electrodes is GYC.
相关临床试验
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：GYC）
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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