Qura S.R.L · Class II · Cleared Nov 8, 2023
| K-number | K231773 |
| Device name | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U |
| Applicant | Qura S.R.L |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Nov 8, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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