K983838 is an FDA 510(k) clearance for the ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP. 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 November 20, 1998, 30 days after receiving the submission on October 21, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K983838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1998 |
| Decision Date | November 20, 1998 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |