Maxtec MaxBlend2+p 医療設備規範文本翻譯： Maxtec MaxBlend2+p 医療設備規範文本
K 號：K231895 · 2023-12-04
廣告
器材摘要
Maxtec MaxBlend2+p is the device name listed in this FDA 510(k) record. The listed applicant is Maxtec, LLC. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K231895. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Maxtec MaxBlend2+p?
Maxtec MaxBlend2+p is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is Maxtec, LLC. The 510(k) number is K231895.
When did Maxtec MaxBlend2+p receive FDA 510(k) clearance?
Maxtec MaxBlend2+p received FDA 510(k) clearance on 2023-12-04, under 510(k) number K231895.
Who is the listed applicant for Maxtec MaxBlend2+p?
The FDA 510(k) record lists Maxtec, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Maxtec MaxBlend2+p?
The FDA product code for Maxtec MaxBlend2+p is BZR.
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。
其他以 Maxtec, LLC 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：BZR）
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。
K243917F&P Optiflow 氧氣/空氣流量來源Fisher & Paykel Healthcare, Ltd.K241465米達流量計；電子自動化測量系統Parker Hannifin CorporationK230987FlowStar 模擬混合流量計Baldus Sedation GmbH & Co. KGK222794FlowStar Touch數位混合流量計Baldus Sedation GmbH & Co. KGK221494品質混合攪拌機，氧氣攪拌機Dehas Medical Systems GmbHK202480尼特羅克斯 Plus 0-70，尼特羅克斯 0-50，尼特羅克斯 Plus 50/50Parker Hannifin
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