AirRay硬膜下皮質電極
K 號：K183437 · 2019-03-12
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器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：GYC）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
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