K041738 is an FDA 510(k) clearance for the BAXTER INFUSOR SV (SMALL VOLUME). This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on July 9, 2004, 11 days after receiving the submission on June 28, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K041738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2004 |
| Decision Date | July 09, 2004 |
| Days to Decision | 11 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |