The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Heat Exchanger Reservoir Module.
| Device ID | K812093 |
| 510k Number | K812093 |
| Device Name: | COBE HEAT EXCHANGER RESERVOIR MODULE |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-24 |
| Decision Date | 1981-08-13 |