MQS — System, Hemodialysis, Access Recirculation Monitoring Class II
FDA product code MQS covers "System, Hemodialysis, Access Recirculation Monitoring", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MQS
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232283 | physician software systems | PhySoftAMS® | December 14, 2023 |
| K180410 | dosis | Dosis SAM | January 16, 2019 |
| K130579 | physicians software systems | PHYSOFT AMS | December 19, 2013 |
| K042566 | vasc-alert | VASC-ALERT | November 8, 2004 |
| K022963 | transonic systems | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | December 4, 2002 |
| K021571 | transonic systems | TRANSONIC FLOW-QC SET MODEL ADT1010 | August 12, 2002 |
| K001763 | in-line diagnostics | CRIT-LINE MONITOR III (CLM III) | December 20, 2000 |
| K993587 | hewlett-packard | HP M2376A DEVICE LINK SYSTEM | January 20, 2000 |
| K992227 | in-line diagnostics | CRIT-LINE MONITOR III (CLM III) | July 30, 1999 |
| K984194 | hewlett-packard | HP M2376A DEVICE LINK SYSTEM | April 30, 1999 |
| K982412 | in-line diagnostics | MODIFICATION OF CRIT-LINE MONITOR III (CLM III) | October 9, 1998 |
| K980906 | transonic systems | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO | October 6, 1998 |
| K972470 | in-line diagnostics | CRIT-LINE MONITOR (CLMIII) | December 11, 1997 |
| K960817 | transonic systems | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) | February 11, 1997 |
| K954003 | cobe renal care | COBE HEMODYNAMIC RECIRCULATION MONITOR | February 6, 1997 |
| K953875 | in-line diagnostics | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | July 23, 1996 |
| K941460 | fresenius usa | FRESENIUS BLOOD TEMPERATURE MONITOR | July 3, 1996 |
| K953551 | h and h control systems | KNOW-RECIRC | June 21, 1996 |