The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for H-tron V 100 Insulin Infusion Pump.
Device ID | K905693 |
510k Number | K905693 |
Device Name: | H-TRON V 100 INSULIN INFUSION PUMP |
Classification | Pump, Infusion, Insulin |
Applicant | DISETRONIC MEDICAL SYSTEMS 13911 RIDGEDALE DR. SUITE 254 Minnetonka, MN 55343 |
Contact | Jim Myers |
Correspondent | Jim Myers DISETRONIC MEDICAL SYSTEMS 13911 RIDGEDALE DR. SUITE 254 Minnetonka, MN 55343 |
Product Code | LZG |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-19 |
Decision Date | 1991-04-12 |