K031249 is an FDA 510(k) clearance for the MODIFICATION TO STRYKER PAINPUMP. 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 July 21, 2003, 94 days after receiving the submission on April 18, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K031249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2003 |
| Decision Date | July 21, 2003 |
| Days to Decision | 94 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 |