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 |