FDA 510(k)

QualityFlow O2シリーズ（QualityFLOW O2）；QualityFlow O2シリーズ（QualityFLOW O2 MTV）

K番号: K241366 · 2024-10-29

決定日2024-10-29

製品コードCBP

諮問委員会AN 当社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書およびPMA（プレマーケティング評価）を通じて承認を受けています。臨床試験情報は、NCT（臨床試験登録番号）およびPMID（PubMed ID）で確認できます。詳細情報や製品の詳細については、以下のURLをご参照ください。 [URL]

決定大幅同等

医療機器の概要

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) 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 2024-10-29 under 510(k) number K241366. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Dehas Medical Systems GmbH. The 510(k) number is K241366.

When did QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) receive FDA 510(k) clearance?

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K241366.

Who is the listed applicant for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

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 QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

The FDA product code for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is CBP.

申請者としてDehas Medical Systems GmbHを記載するその他の記録

K221494品質ミックスブレンダー、オキシミキサー

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