K130394 is an FDA 510(k) clearance for the CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0. This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by Smiths Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 9, 2013, 297 days after receiving the submission on February 15, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K130394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2013 |
| Decision Date | December 09, 2013 |
| Days to Decision | 297 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEA — Pump, Infusion, Pca |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |