K200051 is an FDA 510(k) clearance for the PUGGLE Enteral Feeding Pump and Feeding Set. 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 September 25, 2020, 259 days after receiving the submission on January 10, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K200051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2020 |
| Decision Date | September 25, 2020 |
| Days to Decision | 259 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 |