K003543 is an FDA 510(k) clearance for the STRYKER PAINPUMP PCA. 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 June 5, 2001, 200 days after receiving the submission on November 17, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K003543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2000 |
| Decision Date | June 05, 2001 |
| Days to Decision | 200 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 |