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 |