K042566 is an FDA 510(k) clearance for the VASC-ALERT, a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by Vasc-Alert, Inc. (Chicago, US). The FDA issued a Cleared decision on November 8, 2004, 48 days after receiving the submission on September 21, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K042566 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 21, 2004 |
| Decision Date | November 08, 2004 |
| Days to Decision | 48 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 |