K110901 is an FDA 510(k) clearance for the SYMBIQ INFUSION AND ADMINSTRATION SET. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 5, 2012, 340 days after receiving the submission on March 31, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K110901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2011 |
| Decision Date | March 05, 2012 |
| Days to Decision | 340 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 |