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 |