The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Modification To D-tronplus.
| Device ID | K043000 |
| 510k Number | K043000 |
| Device Name: | MODIFICATION TO D-TRONPLUS |
| Classification | Pump, Infusion, Insulin |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2004-12-01 |
| Summary: | summary |