K021060 is an FDA 510(k) clearance for the FRESENIUS ICARE MONITORING SYSTEM. This device is classified as a System, Dialysate Delivery, Single Patient (Class II - Special Controls, product code FKP).
Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on November 13, 2002, 225 days after receiving the submission on April 2, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K021060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2002 |
| Decision Date | November 13, 2002 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKP — System, Dialysate Delivery, Single Patient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |