迷你PCNL系統
K 號：K200770 · 2021-07-30
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器材摘要
Mini PCNL-System is the device name listed in this FDA 510(k) record. The listed applicant is Trokamed GmbH. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K200770. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Mini PCNL-System?
Mini PCNL-System is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Trokamed GmbH. The 510(k) number is K200770.
When did Mini PCNL-System receive FDA 510(k) clearance?
Mini PCNL-System received FDA 510(k) clearance on 2021-07-30, under 510(k) number K200770.
Who is the listed applicant for Mini PCNL-System?
The FDA 510(k) record lists Trokamed GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mini PCNL-System?
The FDA product code for Mini PCNL-System is FED.
相關臨床試驗
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相關器械（代碼：FED）
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
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