K030661 is an FDA 510(k) clearance for the STRYKER PAINPUMP2. This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 30, 2003, 88 days after receiving the submission on March 3, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K030661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2003 |
| Decision Date | May 30, 2003 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEA — Pump, Infusion, Pca |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |