The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311.
Device ID | K021974 |
510k Number | K021974 |
Device Name: | MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 |
Classification | Accessories, Pump, Infusion |
Applicant | MINIMED, INC. 18000 DEVONSHIRE ST. Northridge, CA 91325 |
Contact | Gerda Resch |
Correspondent | Gerda Resch MINIMED, INC. 18000 DEVONSHIRE ST. Northridge, CA 91325 |
Product Code | MRZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-06-17 |
Decision Date | 2002-08-06 |
Summary: | summary |