The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic Dolomat Pump.
| Device ID | K920063 |
| 510k Number | K920063 |
| Device Name: | DISETRONIC DOLOMAT PUMP |
| Classification | Scale, Patient |
| 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 | FRW |
| CFR Regulation Number | 880.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-07 |
| Decision Date | 1993-08-03 |