The following data is part of a premarket notification filed by Spectrum Medical Ltd. with the FDA for Quantum Heater-cooler.
| Device ID | K212657 |
| 510k Number | K212657 |
| Device Name: | Quantum Heater-Cooler |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | Spectrum Medical Ltd. Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GB Gl29ql |
| Contact | Colleen Powell |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2022-05-06 |
| Summary: | summary |