K163657 is an FDA 510(k) clearance for the Quantum Workstation. 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 January 18, 2017, 26 days after receiving the submission on December 23, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4330.
| 510(k) Number | K163657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2016 |
| Decision Date | January 18, 2017 |
| Days to Decision | 26 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 |