MQS
- Product code
- MQS
- Device name
- System, Hemodialysis, Access Recirculation Monitoring
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 18 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232283 | 2023-12-14 | Physician Software Systems, LLC | PhySoftAMS® |
Official FDA classification page: MQS
Classification and pathway per current FDA publications. Data from openFDA (CC0).