K130579 is an FDA 510(k) clearance for the PHYSOFT AMS, a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by Physicians Software Systems, LLC (Lisle, US). The FDA issued a Cleared decision on December 19, 2013, 289 days after receiving the submission on March 5, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K130579 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 05, 2013 |
| Decision Date | December 19, 2013 |
| Days to Decision | 289 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MQS — System, Hemodialysis, Access Recirculation Monitoring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |