The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Electromedics Blood Heat Exchanger.
| Device ID | K934355 |
| 510k Number | K934355 |
| Device Name: | ELECTROMEDICS BLOOD HEAT EXCHANGER |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Contact | Harold W Bryan |
| Correspondent | Harold W Bryan ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1993-12-03 |