The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic H-tron Plus V 100 Insulin Infusion Pump.
| Device ID | K973044 |
| 510k Number | K973044 |
| Device Name: | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 Minneapolis, MN 55421 -1014 |
| Contact | Jim Myers |
| Correspondent | Jim Myers DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 Minneapolis, MN 55421 -1014 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-15 |
| Decision Date | 1997-09-15 |