K041317 is an FDA 510(k) clearance for the MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on July 19, 2004, 62 days after receiving the submission on May 18, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K041317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2004 |
| Decision Date | July 19, 2004 |
| Days to Decision | 62 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |