The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic D-modem.
| Device ID | K943952 |
| 510k Number | K943952 |
| Device Name: | DISETRONIC D-MODEM |
| Classification | Pump, Infusion |
| Applicant | DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 Minneapolis, MN 55421 -1014 |
| Contact | James J Myers |
| Correspondent | James J Myers DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 Minneapolis, MN 55421 -1014 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-15 |
| Decision Date | 1995-10-07 |