K831132 is an FDA 510(k) clearance for the COMPUDIAL/KP-1. This device is classified as a Dialyzer Reprocessing System (Class II - Special Controls, product code LIF).
Submitted by Computer Dialysis Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983, 124 days after receiving the submission on April 6, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K831132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1983 |
| Decision Date | August 08, 1983 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LIF — Dialyzer Reprocessing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |