The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Accu-chek Insulin Pump Configuration Software (standard), Model 04625137001; Accu-chek Insulin Pump Configuration Softwa.
| Device ID | K060876 |
| 510k Number | K060876 |
| Device Name: | ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA |
| Classification | Pump, Infusion, Insulin |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-31 |
| Decision Date | 2006-06-15 |
| Summary: | summary |