通訊外科口罩，配透明視窗
K 號：K152561 · 2016-06-03
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器材摘要
Communicator Surgical Facemask with Clear Window is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech , Ltd.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152561. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Communicator Surgical Facemask with Clear Window?
Communicator Surgical Facemask with Clear Window is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Prestige Ameritech , Ltd.. The 510(k) number is K152561.
When did Communicator Surgical Facemask with Clear Window receive FDA 510(k) clearance?
Communicator Surgical Facemask with Clear Window received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152561.
Who is the listed applicant for Communicator Surgical Facemask with Clear Window?
The FDA 510(k) record lists Prestige Ameritech , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Communicator Surgical Facemask with Clear Window?
The FDA product code for Communicator Surgical Facemask with Clear Window is FXX.
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：FXX）
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
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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