The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic(r) Infusor.
| Device ID | K913891 |
| 510k Number | K913891 |
| Device Name: | DISETRONIC(R) INFUSOR |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-30 |
| Decision Date | 1992-03-27 |