The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for D6zo Disposable Heat Exchanger.
| Device ID | K813264 |
| 510k Number | K813264 |
| Device Name: | D6ZO DISPOSABLE HEAT EXCHANGER |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, 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 | 1981-11-20 |
| Decision Date | 1982-07-06 |