MiniBox +
K 號：K161295 · 2016-10-21
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器材摘要
MiniBox + is the device name listed in this FDA 510(k) record. The listed applicant is Pulmone Advanced Medical Devices, Ltd.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K161295. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MiniBox +?
MiniBox + is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Pulmone Advanced Medical Devices, Ltd.. The 510(k) number is K161295.
When did MiniBox + receive FDA 510(k) clearance?
MiniBox + received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161295.
Who is the listed applicant for MiniBox +?
The FDA 510(k) record lists Pulmone Advanced Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MiniBox +?
The FDA product code for MiniBox + is BZC.
相關臨床試驗
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相關器械（代碼：BZC）
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。
K240293STS
請注意，這裡的 "STS" 似乎是一個設備名稱或識別碼，並未提供完整的文檔內容，因此無法進行完整的翻譯。如果您能提供完整的文檔內容，我將能夠提供正確的翻譯。Techbopulm, Ltd.K183567維恩圖斯/哨兵套件產品線Vyaire MedicalK190853維恩塔斯BODYVyaire Medical, Inc.K181524Vyntus ONE 配 CART，Vyntus ONE PFT 只配 CART，Vyntus ONE 配可調節 CART，Vyntus ONE PFT 只配可調節 CARTVyaire Medical, Inc.K162515COSMED K5 穿著式代謝技術Cosmed Srl
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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