The following data is part of a premarket notification filed by Hedeco with the FDA for Keofeed 500 Enteric Feeding Pump.
| Device ID | K820063 |
| 510k Number | K820063 |
| Device Name: | KEOFEED 500 ENTERIC FEEDING PUMP |
| Classification | Pump, Infusion |
| Applicant | HEDECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-11 |
| Decision Date | 1982-02-10 |