K124018 is an FDA 510(k) clearance for the AMIA AUTOMATED PD SYSTEM. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on June 14, 2013, 169 days after receiving the submission on December 27, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K124018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2012 |
| Decision Date | June 14, 2013 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKX - System, Peritoneal, Automatic Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |