醫療外科口罩-型號 MP002-5, MP002-6
K 號：K202577 · 2021-01-11
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決定日期2021-01-11
產品代碼FXX
諮詢委員會SU
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決定相當於
器材摘要
Medical Surgical Mask-Model MP002-5, MP002-6 is the device name listed in this FDA 510(k) record. The listed applicant is Jiangmen Sure&Me Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2021-01-11 under 510(k) number K202577. 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 Medical Surgical Mask-Model MP002-5, MP002-6?
Medical Surgical Mask-Model MP002-5, MP002-6 is a medical device that received FDA 510(k) clearance on 2021-01-11. The listed applicant is Jiangmen Sure&Me Medical Product Co., Ltd.. The 510(k) number is K202577.
When did Medical Surgical Mask-Model MP002-5, MP002-6 receive FDA 510(k) clearance?
Medical Surgical Mask-Model MP002-5, MP002-6 received FDA 510(k) clearance on 2021-01-11, under 510(k) number K202577.
Who is the listed applicant for Medical Surgical Mask-Model MP002-5, MP002-6?
The FDA 510(k) record lists Jiangmen Sure&Me Medical Product Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medical Surgical Mask-Model MP002-5, MP002-6?
The FDA product code for Medical Surgical Mask-Model MP002-5, MP002-6 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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