Irrigo 溝洗傷口噴射系統
K 號：K210987 · 2022-05-31
廣告
申請人Inopro, Inc.
決定日期2022-05-31
產品代碼FQH
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
IRRIGO Wound Wash Jet System is the device name listed in this FDA 510(k) record. The listed applicant is Inopro, Inc.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K210987. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the IRRIGO Wound Wash Jet System?
IRRIGO Wound Wash Jet System is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Inopro, Inc.. The 510(k) number is K210987.
When did IRRIGO Wound Wash Jet System receive FDA 510(k) clearance?
IRRIGO Wound Wash Jet System received FDA 510(k) clearance on 2022-05-31, under 510(k) number K210987.
Who is the listed applicant for IRRIGO Wound Wash Jet System?
The FDA 510(k) record lists Inopro, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IRRIGO Wound Wash Jet System?
The FDA product code for IRRIGO Wound Wash Jet System is FQH.
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：FQH）
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。
廣告