ID-Cap系統
K 號：K183052 · 2019-12-06
廣告
決定日期2019-12-06
產品代碼OZW
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
ID-Cap System is the device name listed in this FDA 510(k) record. The listed applicant is Etectrx, Inc.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K183052. The device is classified under product code OZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ID-Cap System?
ID-Cap System is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Etectrx, Inc.. The 510(k) number is K183052.
When did ID-Cap System receive FDA 510(k) clearance?
ID-Cap System received FDA 510(k) clearance on 2019-12-06, under 510(k) number K183052.
Who is the listed applicant for ID-Cap System?
The FDA 510(k) record lists Etectrx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ID-Cap System?
The FDA product code for ID-Cap System is OZW.
相關臨床試驗
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。
相關器械（代碼：OZW）
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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