K913958 is an FDA 510(k) clearance for the FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP. This device is classified as a Pump, Infusion, Enteral (Class II - Special Controls, product code LZH).
Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on February 7, 1992, 155 days after receiving the submission on September 5, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K913958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1991 |
| Decision Date | February 07, 1992 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LZH — Pump, Infusion, Enteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |