智慧顱部設備
K 號：K190162 · 2019-10-17
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器材摘要
SmartCeph is the device name listed in this FDA 510(k) record. The listed applicant is Ortho2, LLC. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K190162. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SmartCeph?
SmartCeph is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Ortho2, LLC. The 510(k) number is K190162.
When did SmartCeph receive FDA 510(k) clearance?
SmartCeph received FDA 510(k) clearance on 2019-10-17, under 510(k) number K190162.
Who is the listed applicant for SmartCeph?
The FDA 510(k) record lists Ortho2, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartCeph?
The FDA product code for SmartCeph is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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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