The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Medtronic Minimed Paradigm Model 512 Insulin Pump And The Bd Paradigm Link Glucose Meter.
| Device ID | K030531 |
| 510k Number | K030531 |
| Device Name: | MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER |
| Classification | Pump, Infusion, Insulin |
| Applicant | MINIMED, INC. 18000 DEVONSHIRE ST. Northridge, CA 91325 |
| Contact | Gerda P Resch |
| Correspondent | Gerda P Resch MINIMED, INC. 18000 DEVONSHIRE ST. Northridge, CA 91325 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-02-19 |
| Decision Date | 2003-06-17 |
| Summary: | summary |