K151650 is an FDA 510(k) clearance for the SMARTez elastomeric infusion pump. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on April 4, 2016, 291 days after receiving the submission on June 18, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K151650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2015 |
| Decision Date | April 04, 2016 |
| Days to Decision | 291 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 |