MQS — System, Hemodialysis, Access Recirculation Monitoring Class II
FDA Device Classification
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 |