智能框架 OR
K 號：K233141 · 2024-01-12
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器材摘要
SmartFrame OR is the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233141. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SmartFrame OR?
SmartFrame OR is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K233141.
When did SmartFrame OR receive FDA 510(k) clearance?
SmartFrame OR received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233141.
Who is the listed applicant for SmartFrame OR?
The FDA 510(k) record lists ClearPoint Neuro, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartFrame OR?
The FDA product code for SmartFrame OR is HAW.
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其他以 ClearPoint Neuro, Inc. 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：HAW）
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。
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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