The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Heat Exchanger, Fhx-14.
| Device ID | K781210 |
| 510k Number | K781210 |
| Device Name: | HEAT EXCHANGER, FHX-14 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | DELTA MEDICAL INDUSTRIES 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 | 1978-07-17 |
| Decision Date | 1978-10-10 |