K232283 is an FDA 510(k) clearance for the PhySoftAMS®. This device is classified as a System, Hemodialysis, Access Recirculation Monitoring (Class II - Special Controls, product code MQS).
Submitted by Physician Software Systems, LLC (Lisle, US). The FDA issued a Cleared decision on December 14, 2023, 136 days after receiving the submission on July 31, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K232283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2023 |
| Decision Date | December 14, 2023 |
| Days to Decision | 136 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 |