Submission Details
| 510(k) Number | K043600 FDA.gov |
| FDA Decision | Cleared 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 |
K043600 is an FDA 510(k) clearance for the MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C, 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 review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K043600 FDA.gov |
| FDA Decision | Cleared 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 |