OneRF 消融系統
K 號：K231675 · 2023-12-06
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器材摘要
OneRF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Neuroone Medical Technologies Corp.. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K231675. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OneRF Ablation System?
OneRF Ablation System is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Neuroone Medical Technologies Corp.. The 510(k) number is K231675.
When did OneRF Ablation System receive FDA 510(k) clearance?
OneRF Ablation System received FDA 510(k) clearance on 2023-12-06, under 510(k) number K231675.
Who is the listed applicant for OneRF Ablation System?
The FDA 510(k) record lists Neuroone Medical Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OneRF Ablation System?
The FDA product code for OneRF Ablation System is GXD.
相關臨床試驗
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其他以 Neuroone Medical Technologies Corp. 為申請人之記錄
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。
相關器械（代碼：GXD）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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