K003047 is an FDA 510(k) clearance for the AMBULATORY ENTERAL NUTRITION PUMP. This device is classified as a Pump, Infusion, Enteral (Class II - Special Controls, product code LZH).
Submitted by Ross Product Div. Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on June 12, 2001, 256 days after receiving the submission on September 29, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K003047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2000 |
| Decision Date | June 12, 2001 |
| Days to Decision | 256 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 |