FDA 510(k) Applications for Medical Device Product Code "MQS"
(System, Hemodialysis, Access Recirculation Monitoring)

FDA 510(k) Number Applicant Device Name Decision Date
K954003 COBE RENAL CARE, INC. COBE HEMODYNAMIC RECIRCULATION MONITOR 02/06/1997
K180410 Dosis, Inc. Dosis SAM 01/16/2019
K941460 FRESENIUS USA, INC. FRESENIUS BLOOD TEMPERATURE MONITOR 07/03/1996
K953551 H&H CONTROL SYSTEMS KNOW-RECIRC 06/21/1996
K984194 HEWLETT-PACKARD CO. HP M2376A DEVICE LINK SYSTEM 04/30/1999
K993587 HEWLETT-PACKARD CO. HP M2376A DEVICE LINK SYSTEM 01/20/2000
K953875 IN-LINE DIAGNOSTICS CORP. CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) 07/23/1996
K972470 IN-LINE DIAGNOSTICS CORP. CRIT-LINE MONITOR (CLMIII) 12/11/1997
K992227 IN-LINE DIAGNOSTICS CORP. CRIT-LINE MONITOR III (CLM III) 07/30/1999
K001763 IN-LINE DIAGNOSTICS CORP. CRIT-LINE MONITOR III (CLM III) 12/20/2000
K982412 IN-LINE DIAGNOSTICS CORP. MODIFICATION OF CRIT-LINE MONITOR III (CLM III) 10/09/1998
K130579 PHYSICIANS SOFTWARE SYSTEMS, LLC PHYSOFT AMS 12/19/2013
K960817 TRANSONIC SYSTEMS, INC. HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) 02/11/1997
K021571 TRANSONIC SYSTEMS, INC. TRANSONIC FLOW-QC SET MODEL ADT1010 08/12/2002
K980906 TRANSONIC SYSTEMS, INC. TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO 10/06/1998
K022963 TRANSONIC SYSTEMS, INC. TRANSONIC SYRINGE WARMER, MODEL SYR-1000 12/04/2002
K042566 VASC-ALERT, INC. VASC-ALERT 11/08/2004


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