The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Minimed Paradigm Insulin Pump, Model 511.
| Device ID | K001829 |
| 510k Number | K001829 |
| Device Name: | MINIMED PARADIGM INSULIN PUMP, MODEL 511 |
| Classification | Pump, Infusion |
| Applicant | MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Jennifer Lyons |
| Correspondent | Jennifer Lyons MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-16 |
| Decision Date | 2000-08-18 |