K874181 is an FDA 510(k) clearance for the BAXTER BEDSIDE SYSTEM. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on February 22, 1988, 131 days after receiving the submission on October 14, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K874181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1987 |
| Decision Date | February 22, 1988 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |