凱麗特導航儀器系統
K 號：K232572 · 2023-12-13
廣告
決定日期2023-12-13
產品代碼OLO
諮詢委員會NE
(請提供完整的英文描述，以便進行翻譯。)
決定相當於
器材摘要
Kalitec Navigated Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC Doing Business AS Kalitec Medical. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K232572. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Kalitec Navigated Instrument System?
Kalitec Navigated Instrument System is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Kalitec Direct, LLC Doing Business AS Kalitec Medical. The 510(k) number is K232572.
When did Kalitec Navigated Instrument System receive FDA 510(k) clearance?
Kalitec Navigated Instrument System received FDA 510(k) clearance on 2023-12-13, under 510(k) number K232572.
Who is the listed applicant for Kalitec Navigated Instrument System?
The FDA 510(k) record lists Kalitec Direct, LLC Doing Business AS Kalitec Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kalitec Navigated Instrument System?
The FDA product code for Kalitec Navigated Instrument System is OLO.
相關臨床試驗
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相關器械（代碼：OLO）
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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