K043466 is an FDA 510(k) clearance for the PAINPUMP2. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 10, 2005, 146 days after receiving the submission on December 15, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K043466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2004 |
| Decision Date | May 10, 2005 |
| Days to Decision | 146 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 |