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FDA 510(k)

Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

Número K: K231982 · 2024-09-12

RequerenteQura S.R.L
Data da decisão2024-09-12
Código do produtoDTZ
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: DTZ)

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Fonte oficial

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