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 |