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 |