K002380 is an FDA 510(k) clearance for the INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 5, 2000, 32 days after receiving the submission on August 4, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K002380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2000 |
| Decision Date | September 05, 2000 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| 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 |