FDA Product Code
FDA Product Code MQS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023-12-14 | Traditional | PDF ↗ |
| K180410 | Dosis SAM | Dosis, Inc. | 2019-01-16 | Traditional | PDF ↗ |
| K130579 | PHYSOFT AMS | Physicians Software Systems, LLC | 2013-12-19 | Traditional | PDF ↗ |
| K042566 | VASC-ALERT | Vasc-Alert, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | Transonic Systems, Inc. | 2002-12-04 | Traditional | PDF ↗ |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | Transonic Systems, Inc. | 2002-08-12 | Traditional | PDF ↗ |
| K001763 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 2000-12-20 | Traditional | PDF ↗ |
| K993587 | HP M2376A DEVICE LINK SYSTEM | Hewlett-Packard Co. | 2000-01-20 | Traditional | PDF ↗ |
| K992227 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1999-07-30 | Special | PDF ↗ |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Hewlett-Packard Co. | 1999-04-30 | Traditional | PDF ↗ |
| K982412 | MODIFICATION OF CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1998-10-09 | Traditional | PDF ↗ |
| K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO | Transonic Systems, Inc. | 1998-10-06 | Traditional | PDF ↗ |
| K972470 | CRIT-LINE MONITOR (CLMIII) | In-Line Diagnostics Corp. | 1997-12-11 | Traditional | PDF ↗ |
| K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR | Cobe Renal Care, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | In-Line Diagnostics Corp. | 1996-07-23 | Traditional | PDF ↗ |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | Fresenius USA, Inc. | 1996-07-03 | Traditional | PDF ↗ |
| K953551 | KNOW-RECIRC | H&H Control Systems | 1996-06-21 | Traditional | PDF ↗ |
Product code MQS · Class II · Gastroenterology, Urology. Data: openFDA.