The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantum Workstation.
| Device ID | K163657 |
| 510k Number | K163657 |
| Device Name: | Quantum Workstation |
| 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 | Mark Drain |
| Correspondent | Mark Drain 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 | 2016-12-23 |
| Decision Date | 2017-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060434420671 | K163657 | 000 |
| 05060434422521 | K163657 | 000 |
| 05060434422989 | K163657 | 000 |
| 05060434422996 | K163657 | 000 |
| 05060434423009 | K163657 | 000 |
| 05060434423016 | K163657 | 000 |
| 05060434422293 | K163657 | 000 |
| 05060434420008 | K163657 | 000 |
| 05060434420602 | K163657 | 000 |
| 05060434420619 | K163657 | 000 |
| 05060434420626 | K163657 | 000 |
| 05060434420633 | K163657 | 000 |
| 05060434420640 | K163657 | 000 |
| 05060434420657 | K163657 | 000 |
| 05060434420664 | K163657 | 000 |
| 05060434422279 | K163657 | 000 |