The following data is part of a premarket notification filed by Imed Corp. with the FDA for Infusion Pump, Pediatric Model 301.
| Device ID | K781171 |
| 510k Number | K781171 |
| Device Name: | INFUSION PUMP, PEDIATRIC MODEL 301 |
| Classification | Pump, Infusion |
| Applicant | IMED CORP. 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 | 1978-07-13 |
| Decision Date | 1978-08-10 |