The following data is part of a premarket notification filed by Nipro Diabetes Systems, Inc. with the FDA for Amigo Insulin Pump.
| Device ID | K050312 |
| 510k Number | K050312 |
| Device Name: | AMIGO INSULIN PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | NIPRO DIABETES SYSTEMS, INC. 3361 ENTERPRISE WAY Miramar, FL 33025 |
| Contact | Clarence Odom |
| Correspondent | Clarence Odom NIPRO DIABETES SYSTEMS, INC. 3361 ENTERPRISE WAY Miramar, FL 33025 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-08 |
| Decision Date | 2005-05-09 |
| Summary: | summary |