K111275 is an FDA 510(k) clearance for the CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Smiths Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 1, 2013, 637 days after receiving the submission on May 6, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K111275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2011 |
| Decision Date | February 01, 2013 |
| Days to Decision | 637 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 |