數位導引系統
K 號：K193499 · 2020-11-04
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器材摘要
DigiGuide System is the device name listed in this FDA 510(k) record. The listed applicant is Protomed, Inc.. It received FDA 510(k) clearance on 2020-11-04 under 510(k) number K193499. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DigiGuide System?
DigiGuide System is a medical device that received FDA 510(k) clearance on 2020-11-04. The listed applicant is Protomed, Inc.. The 510(k) number is K193499.
When did DigiGuide System receive FDA 510(k) clearance?
DigiGuide System received FDA 510(k) clearance on 2020-11-04, under 510(k) number K193499.
Who is the listed applicant for DigiGuide System?
The FDA 510(k) record lists Protomed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DigiGuide System?
The FDA product code for DigiGuide System is DZJ.
相關臨床試驗
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相關器械（代碼：DZJ）
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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