The following data is part of a premarket notification filed by Alpha Omega, Inc. with the FDA for Alpha Omega Dual Cooler-heater.
| Device ID | K001520 |
| 510k Number | K001520 |
| Device Name: | ALPHA OMEGA DUAL COOLER-HEATER |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | ALPHA OMEGA, INC. 2525 HARTFORD RD. Austin, TX 78703 |
| Contact | Richard Martin |
| Correspondent | Richard Martin ALPHA OMEGA, INC. 2525 HARTFORD RD. Austin, TX 78703 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-16 |
| Decision Date | 2000-11-22 |