神一皮質電極
K 號：K192764 · 2019-11-26
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器材摘要
NeuroOne Cortical Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Neuroone, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192764. 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 NeuroOne Cortical Electrode?
NeuroOne Cortical Electrode is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Neuroone, Inc.. The 510(k) number is K192764.
When did NeuroOne Cortical Electrode receive FDA 510(k) clearance?
NeuroOne Cortical Electrode received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192764.
Who is the listed applicant for NeuroOne Cortical Electrode?
The FDA 510(k) record lists Neuroone, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeuroOne Cortical Electrode?
The FDA product code for NeuroOne Cortical Electrode 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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