FDA 510(k)

品質混合攪拌機，氧氣攪拌機

K 號：K221494 · 2023-01-23

決定日期2023-01-23

產品代碼BZR

諮詢委員會AN

決定相當於

器材摘要

Quality Mix Blender, Oxymixer is the device name listed in this FDA 510(k) record. The listed applicant is Dehas Medical Systems GmbH. It received FDA 510(k) clearance on 2023-01-23 under 510(k) number K221494. 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 Quality Mix Blender, Oxymixer?

Quality Mix Blender, Oxymixer is a medical device that received FDA 510(k) clearance on 2023-01-23. The listed applicant is Dehas Medical Systems GmbH. The 510(k) number is K221494.

When did Quality Mix Blender, Oxymixer receive FDA 510(k) clearance?

Quality Mix Blender, Oxymixer received FDA 510(k) clearance on 2023-01-23, under 510(k) number K221494.

Who is the listed applicant for Quality Mix Blender, Oxymixer?

The FDA 510(k) record lists Dehas Medical Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quality Mix Blender, Oxymixer?

The FDA product code for Quality Mix Blender, Oxymixer is BZR.

其他以 Dehas Medical Systems GmbH 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。

K241366QualityFlow O2 系列產品（QualityFLOW O2）；QualityFlow O2 系列產品（QualityFLOW O2 MTV）

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。

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