The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure.
| Device ID | K192838 |
| 510k Number | K192838 |
| Device Name: | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure |
| Classification | Control, Pump Speed, 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 | DWA |
| Subsequent Product Code | DTQ |
| Subsequent Product Code | KFM |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-03 |
| Decision Date | 2020-04-13 |