K043600 is an FDA 510(k) clearance for the MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on March 29, 2005, 90 days after receiving the submission on December 29, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K043600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2004 |
| Decision Date | March 29, 2005 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |