K202557 is an FDA 510(k) clearance for the Quantum Workstation 12 Elite. This device is classified as a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DRY).
Submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on October 2, 2020, 29 days after receiving the submission on September 3, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4330.
| 510(k) Number | K202557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2020 |
| Decision Date | October 02, 2020 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRY - Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4330 |