K232205 is an FDA 510(k) clearance for the Vesco Q™ Enteral Feeding Pump. This device is classified as a Pump, Infusion, Enteral (Class II - Special Controls, product code LZH).
Submitted by Vesco Medical, LLC (Westerville, US). The FDA issued a Cleared decision on October 23, 2023, 90 days after receiving the submission on July 25, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K232205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2023 |
| Decision Date | October 23, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| 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 |