K992255 is an FDA 510(k) clearance for the CKHEMO, MODEL CKHEMO VERSION 1.0, a System, Dialysate Delivery, Single Patient (Class II — Special Controls, product code FKP), submitted by Csam, Inc. (Bettendorf, US). The FDA issued a Cleared decision on November 30, 1999, 147 days after receiving the submission on July 6, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K992255 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 06, 1999 |
| Decision Date | November 30, 1999 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FKP — System, Dialysate Delivery, Single Patient |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |