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K 號：K223003 · 2022-11-18
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器材摘要
Banded Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Medlink Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K223003. 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 Banded Face Mask?
Banded Face Mask is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Hubei Medlink Healthcare Co., Ltd.. The 510(k) number is K223003.
When did Banded Face Mask receive FDA 510(k) clearance?
Banded Face Mask received FDA 510(k) clearance on 2022-11-18, under 510(k) number K223003.
Who is the listed applicant for Banded Face Mask?
The FDA 510(k) record lists Hubei Medlink Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Banded Face Mask?
The FDA product code for Banded Face Mask is FXX.
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其他以 Hubei Medlink Healthcare Co., Ltd. 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：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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