Fresenius Blood Temperature Monitor
FDA 510(k) K941460 · Fresenius USA, Inc.
510(k) numberK941460
Submission
- Device name
- Fresenius Blood Temperature Monitor
- Applicant
- Fresenius USA, Inc.
Walnut Creek, CA, US - Received
- March 25, 1994
- Decision date
- July 3, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MQS – System, Hemodialysis, Access Recirculation Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code MQS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232283 | PhySoftAMS®MQS · Traditional | Physician Software Systems, LLC | 12/14/2023SE |
| K180410 | Dosis SAMMQS · Traditional | Dosis, Inc. | 01/16/2019SE |
| K130579 | Physoft AmsMQS · Traditional | Physicians Software Systems, LLC | 12/19/2013SE |
| K042566 | Vasc-AlertMQS · Traditional | Vasc-Alert, Inc. | 11/08/2004SE |
| K022963 | Transonic Syringe Warmer, Model SYR-1000MQS · Traditional | Transonic Systems, Inc. | 12/04/2002SE |
| K021571 | Transonic Flow-Qc Set Model ADT1010MQS · Traditional | Transonic Systems, Inc. | 08/12/2002SE |
| K001763 | Crit-Line Monitor III (CLM III)MQS · Traditional | In-Line Diagnostics Corp. | 12/20/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 01/20/2000SE |
| K992227 | Crit-Line Monitor III (CLM III)MQS · Special | In-Line Diagnostics Corp. | 07/30/1999SE |
| K984194 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 04/30/1999SE |
More from Hewlett-Packard Co.
| 510(k) | Device | Decision |
|---|---|---|
| K992275 | Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol…KDI · Special | 08/04/1999SE |
| K970700 | Fresenius Polysulfone Hemodialyzers, Both Low and High FluxMSE · Traditional | 09/15/1998SE |
| K974584 | Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSKDI · Traditional | 05/14/1998SE |
| K973378 | C.A.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model…CAC · Traditional | 11/03/1997SE |
| K961465 | 2008H on Line Clearance MonitorKDI · Traditional | 07/03/1997SE |
| K961706 | P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell SeparatorLKN · Traditional | 07/31/1996SE |
| K955762 | Packpd Peritoneal Dialysis Urea Kinetic Modeling Software ProgramKPF · Traditional | 07/31/1996SE |
| K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFKP · Traditional | 06/13/1996SE |
| K944767 | Dialysis Machine with Dialysate UltrafilterFIP · Traditional | 11/29/1995SE |
| K930181 | Biopure Dialysate Concentrate Mix Syst/ConcentrateFKP · Traditional | 11/29/1995SE |
Questions and answers
When was Fresenius Blood Temperature Monitor cleared by the FDA?
Fresenius Blood Temperature Monitor (K941460) received a 510(k) decision of Substantially Equivalent on July 3, 1996, 831 days after the submission was received.
What is the product code of K941460?
The FDA product code is MQS – System, Hemodialysis, Access Recirculation Monitoring, a Class II (moderate risk) device regulated under 21 CFR 876.5820.