The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantum Ventilation Module.
| Device ID | K181942 |
| 510k Number | K181942 |
| 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 | Mark Drain |
| Correspondent | Mark Drain 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-20 |
| Decision Date | 2018-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060434420688 | K181942 | 000 |
| 05060434420879 | K181942 | 000 |
| 15060434423839 | K181942 | 000 |