The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Electromedics D1079e.
| Device ID | K873561 |
| 510k Number | K873561 |
| Device Name: | ELECTROMEDICS D1079E |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Contact | Dennis Mcelwee |
| Correspondent | Dennis Mcelwee ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-02 |
| Decision Date | 1987-11-05 |