Qura S.R.L · Class II · Cleared Jan 28, 2022
| K-number | K212341 |
| Device name | 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,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U |
| Applicant | Qura S.R.L |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Jan 28, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov