K220230 is an FDA 510(k) clearance for the AMSure Enteral Feeding Pump. This device is classified as a Pump, Infusion, Enteral (Class II - Special Controls, product code LZH).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on November 10, 2022, 287 days after receiving the submission on January 27, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K220230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2022 |
| Decision Date | November 10, 2022 |
| Days to Decision | 287 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 |