K180410 is an FDA 510(k) clearance for the Dosis SAM, a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by Dosis, Inc. (Los Altos, US). The FDA issued a Cleared decision on January 16, 2019, 336 days after receiving the submission on February 14, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K180410 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 2018 |
| Decision Date | January 16, 2019 |
| Days to Decision | 336 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 |