BD Surgiphor™ 抗菌灌洗系統
K 號：K221504 · 2022-10-14
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申請人Bd
決定日期2022-10-14
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
BD Surgiphor™ Antimicrobial Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Bd. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221504. 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 BD Surgiphor™ Antimicrobial Irrigation System?
BD Surgiphor™ Antimicrobial Irrigation System is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Bd. The 510(k) number is K221504.
When did BD Surgiphor™ Antimicrobial Irrigation System receive FDA 510(k) clearance?
BD Surgiphor™ Antimicrobial Irrigation System received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221504.
Who is the listed applicant for BD Surgiphor™ Antimicrobial Irrigation System?
The FDA 510(k) record lists Bd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BD Surgiphor™ Antimicrobial Irrigation System?
The FDA product code for BD Surgiphor™ Antimicrobial Irrigation 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。
其他以 Bd 為申請人之記錄
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。
K253996BD Surgiphor™ 抗菌灌洗系統 (910110)Becton, Dickinson and Company (BD)K253445BD Surgiphor™ 1000 mL 抗菌灌洗系統 (910120)BdK231023ERBEJET® 2 系統Erbe Elektromedizin GmbHK220759Armis VeriCyn 疤痕清潔Armis Biopharma, Inc.K220964VERSAJET 水刀系統 (III)Smith & Nephew Medical LimitedK222804Irrisept 抗菌傷口灌洗器Irrimax Corporation
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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