K051828 is an FDA 510(k) clearance for the NIPRO SUREFUSER AMBULATORY INFUSION PUMP. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by Nipro Medical Corporation (Lexington, US). The FDA issued a Cleared decision on December 15, 2005, 162 days after receiving the submission on July 6, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K051828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2005 |
| Decision Date | December 15, 2005 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEB — Pump, Infusion, Elastomeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |