The following data is part of a premarket notification filed by Spectrum Medical Ltd. with the FDA for Quantum Mini Ventilation Module.
| Device ID | K210669 |
| 510k Number | K210669 |
| Device Name: | Quantum Mini Ventilation Module |
| Classification | Gas Control Unit, Cardiopulmonary Bypass |
| Applicant | Spectrum Medical Ltd. Harrier 4, Meteor Business Park, Cheltenham Road East Gloucestershire, GB Gl29ql |
| Contact | Colleen Powell |
| Correspondent | Colleen Powell Spectrum Medical Ltd. Harrier 4, Meteor Business Park, Cheltenham Road East Gloucestershire, GB Gl29ql |
| Product Code | DTX |
| CFR Regulation Number | 870.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-05 |
| Decision Date | 2021-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060434422798 | K210669 | 000 |
| 05060434422514 | K210669 | 000 |
| 05060434422347 | K210669 | 000 |