K131154 is an FDA 510(k) clearance for the ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET. This device is classified as a Pump, Infusion, Enteral (Class II - Special Controls, product code LZH).
Submitted by Zevex, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 12, 2014, 294 days after receiving the submission on April 24, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K131154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2013 |
| Decision Date | February 12, 2014 |
| Days to Decision | 294 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZH - Pump, Infusion, Enteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |