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 |