BAYLAB 3層外科口罩（BEACON I）
K 號：K212302 · 2021-12-07
廣告
器材摘要
BAYLAB 3-Ply Surgical Mask (BEACON I) is the device name listed in this FDA 510(k) record. The listed applicant is Baylab USA, LLC. It received FDA 510(k) clearance on 2021-12-07 under 510(k) number K212302. 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 BAYLAB 3-Ply Surgical Mask (BEACON I)?
BAYLAB 3-Ply Surgical Mask (BEACON I) is a medical device that received FDA 510(k) clearance on 2021-12-07. The listed applicant is Baylab USA, LLC. The 510(k) number is K212302.
When did BAYLAB 3-Ply Surgical Mask (BEACON I) receive FDA 510(k) clearance?
BAYLAB 3-Ply Surgical Mask (BEACON I) received FDA 510(k) clearance on 2021-12-07, under 510(k) number K212302.
Who is the listed applicant for BAYLAB 3-Ply Surgical Mask (BEACON I)?
The FDA 510(k) record lists Baylab USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BAYLAB 3-Ply Surgical Mask (BEACON I)?
The FDA product code for BAYLAB 3-Ply Surgical Mask (BEACON I) 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。
K251967HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶；HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶，並附帶 WrapAround Visor。O&M Halyard, Inc.K252534外科口罩（耳掛式）Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性外科口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性醫療口罩Makrite Industries, Inc.K243342KP防護口罩Kp Trading Co., Ltd.
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