K960001 is an FDA 510(k) clearance for the MINIMED INFUSION PUMP, MODEL MMT-507. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on April 30, 1996, 119 days after receiving the submission on January 2, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K960001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | January 02, 1996 |
| Decision Date | April 30, 1996 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |