K181942 is an FDA 510(k) clearance for the Quantum Ventilation Module. This device is classified as a Gas Control Unit, Cardiopulmonary Bypass (Class II - Special Controls, product code DTX).
Submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on October 18, 2018, 90 days after receiving the submission on July 20, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4300.
| 510(k) Number | K181942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2018 |
| Decision Date | October 18, 2018 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTX - Gas Control Unit, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4300 |