K081905 is an FDA 510(k) clearance for the ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by Westmed, Inc. (Highlands Ranch, US). The FDA issued a Cleared decision on July 15, 2008, 12 days after receiving the submission on July 3, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K081905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2008 |
| Decision Date | July 15, 2008 |
| Days to Decision | 12 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 |