呼吸套件MDI V1
K 號：K203155 · 2021-09-17
廣告
器材摘要
BreatheSuite MDI V1 is the device name listed in this FDA 510(k) record. The listed applicant is Breathesuite, Inc.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K203155. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BreatheSuite MDI V1?
BreatheSuite MDI V1 is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Breathesuite, Inc.. The 510(k) number is K203155.
When did BreatheSuite MDI V1 receive FDA 510(k) clearance?
BreatheSuite MDI V1 received FDA 510(k) clearance on 2021-09-17, under 510(k) number K203155.
Who is the listed applicant for BreatheSuite MDI V1?
The FDA 510(k) record lists Breathesuite, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BreatheSuite MDI V1?
The FDA product code for BreatheSuite MDI V1 is CAF.
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：CAF）
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。
K254171網狀噴霧器（UN204）；網狀噴霧器（UN205）；網狀噴霧器（UN209）；網狀噴霧器（UN210）Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE 用於噴劑吸入器 (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid 配合 eTrack 系統Pari Respiratory Equipment, Inc.K251659網狀霧化器（H6）Qingdao Future Medical Technology Co., Ltd.K244035攜帶式網狀霧化器（JM821）Shenzhen Jermei Medical Device Technology Co., Ltd.K243468壓縮式霧化器（NB-1100）；壓縮式霧化器（NB-1101）；壓縮式霧化器（NB-1102）；壓縮式霧化器（NB-1103）Joytech Healthcare 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