FDA 510(k)

量子灌流血氧器 VT75-E1，量子灌流血氧器 VT75-E2

K 號：K231982 · 2024-09-12

決定日期2024-09-12

產品代碼DTZ

諮詢委員會履歷

決定相當於

器材摘要

Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 is the device name listed in this FDA 510(k) record. The listed applicant is Qura S.R.L. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K231982. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2?

Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Qura S.R.L. The 510(k) number is K231982.

When did Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 receive FDA 510(k) clearance?

Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 received FDA 510(k) clearance on 2024-09-12, under 510(k) number K231982.

Who is the listed applicant for Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2?

The FDA 510(k) record lists Qura S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2?

The FDA product code for Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 is DTZ.

其他以 Qura S.R.L 為申請人之記錄

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相關器械（代碼：DTZ）

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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