The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantum Workstation 12 Elite.
| Device ID | K202557 |
| 510k Number | K202557 |
| Device Name: | Quantum Workstation 12 Elite |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GB Gl2 9ql |
| Contact | Colleen Powell |
| Correspondent | Colleen Powell Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GB Gl2 9ql |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-03 |
| Decision Date | 2020-10-02 |