K031407 is an FDA 510(k) clearance for the ROSS EMBRACE ENTERAL 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 May 20, 2003, 15 days after receiving the submission on May 5, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K031407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2003 |
| Decision Date | May 20, 2003 |
| Days to Decision | 15 days |
| Submission Type | Special |
| 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 |