The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Modification To Disetronic D-tronplus Insulin Infusion Pump.
| Device ID | K022831 |
| 510k Number | K022831 |
| Device Name: | MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG KIRCHBERSTRASSE 190, POSTFACH Burgdorf, SE Ch-3401 |
| Contact | Sandra Soniec |
| Correspondent | Sandra Soniec DISETRONIC MEDICAL SYSTEMS AG KIRCHBERSTRASSE 190, POSTFACH Burgdorf, SE Ch-3401 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-26 |
| Decision Date | 2002-09-11 |
| Summary: | summary |