K013713 is an FDA 510(k) clearance for the ARM AUTOMATIC REPROCESSING MACHINE. This device is classified as a Dialyzer Reprocessing System (Class II — Special Controls, product code LIF).
Submitted by Alcavis International Incorporated (Gaithersburg, US). The FDA issued a Cleared decision on July 15, 2002, 249 days after receiving the submission on November 8, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K013713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2001 |
| Decision Date | July 15, 2002 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LIF — Dialyzer Reprocessing System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |