The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Open-loop Insulin Delivery System.
| Device ID | K801704 |
| 510k Number | K801704 |
| Device Name: | OPEN-LOOP INSULIN DELIVERY SYSTEM |
| Classification | Pump, Infusion |
| Applicant | DELTA MEDICAL INDUSTRIES 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 | 1980-07-24 |
| Decision Date | 1980-08-13 |