K053177 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E. 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 January 31, 2006, 78 days after receiving the submission on November 14, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K053177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2005 |
| Decision Date | January 31, 2006 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |