Qura S.R.L · Class II · Cleared Dec 17, 2021
| K-number | K203424 |
| Device name | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 |
| Applicant | Qura S.R.L |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Dec 17, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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