Presero 3D 扫描系統
K 號：K190074 · 2019-02-14
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器材摘要
Presero 3D Scanning System is the device name listed in this FDA 510(k) record. The listed applicant is Certis Health. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K190074. 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 Presero 3D Scanning System?
Presero 3D Scanning System is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Certis Health. The 510(k) number is K190074.
When did Presero 3D Scanning System receive FDA 510(k) clearance?
Presero 3D Scanning System received FDA 510(k) clearance on 2019-02-14, under 510(k) number K190074.
Who is the listed applicant for Presero 3D Scanning System?
The FDA 510(k) record lists Certis Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Presero 3D Scanning System?
The FDA product code for Presero 3D Scanning System 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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