The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantum Pump Console.
| Device ID | K173834 |
| 510k Number | K173834 |
| Device Name: | Quantum Pump Console |
| Classification | Console, Heart-lung Machine, 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 | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-18 |
| Decision Date | 2018-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060434420954 | K173834 | 000 |
| 05060434422040 | K173834 | 000 |
| 05060434422453 | K173834 | 000 |
| 05060434423122 | K173834 | 000 |
| 05060434422262 | K173834 | 000 |
| 05060434422316 | K173834 | 000 |
| 05060434422026 | K173834 | 000 |
| 05060434420749 | K173834 | 000 |
| 05060434420756 | K173834 | 000 |
| 05060434420763 | K173834 | 000 |
| 05060434420770 | K173834 | 000 |
| 05060434420787 | K173834 | 000 |
| 05060434420794 | K173834 | 000 |
| 05060434420800 | K173834 | 000 |
| 05060434420824 | K173834 | 000 |
| 05060434423320 | K173834 | 000 |