K120206 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM INSULIN PUMPS. 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 March 29, 2012, 66 days after receiving the submission on January 23, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K120206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2012 |
| Decision Date | March 29, 2012 |
| Days to Decision | 66 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 |