The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Dahedi Insulin Infusion Pump.
| Device ID | K991376 |
| 510k Number | K991376 |
| Device Name: | DAHEDI INSULIN INFUSION PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers, FL 33912 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers, FL 33912 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 1999-06-15 |
| Summary: | summary |