The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantum Ventilation Module.
| Device ID | K202733 |
| 510k Number | K202733 |
| Device Name: | Quantum Ventilation Module |
| Classification | Gas Control Unit, 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 | DTX |
| CFR Regulation Number | 870.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-18 |
| Decision Date | 2020-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060434422743 | K202733 | 000 |
| 05060434421906 | K202733 | 000 |
| 15060434423815 | K202733 | 000 |
| 05060434422699 | K202733 | 000 |
| 05060434422842 | K202733 | 000 |
| 05060434422859 | K202733 | 000 |
| 05060434422064 | K202733 | 000 |
| 05060434422071 | K202733 | 000 |
| 05060434422736 | K202733 | 000 |
| 05060434421890 | K202733 | 000 |