K011096 is an FDA 510(k) clearance for the ABBOTT ACCLAIM ENCORE, MODEL 12237. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 1, 2001, 21 days after receiving the submission on April 10, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K011096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2001 |
| Decision Date | May 01, 2001 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |