FDA 510(k) Applications Submitted by TRANSONIC SYSTEMS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K960817 02/28/1996 HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) TRANSONIC SYSTEMS, INC.
K980906 03/10/1998 TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO TRANSONIC SYSTEMS, INC.
K140740 03/25/2014 TRANSONIC TISSUE PERFUSION MONITOR TRANSONIC SYSTEMS, INC.
K112657 09/13/2011 AUREFLO MONITORING SYSTEM TRANSONIC SYSTEMS, INC.
K080116 01/16/2008 TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM TRANSONIC SYSTEMS, INC.
K010253 01/26/2001 ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 TRANSONIC SYSTEMS, INC.
K021571 05/14/2002 TRANSONIC FLOW-QC SET MODEL ADT1010 TRANSONIC SYSTEMS, INC.
K022963 09/06/2002 TRANSONIC SYRINGE WARMER, MODEL SYR-1000 TRANSONIC SYSTEMS, INC.
K002816 09/11/2000 TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV TRANSONIC SYSTEMS, INC.
K033424 10/23/2003 ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 TRANSONIC SYSTEMS, INC.
K140017 01/02/2014 TRANSONIC HCM 102 SYSTEM TRANSONIC SYSTEMS, INC.
K113821 12/27/2011 TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM TRANSONIC SYSTEMS, INC.
K134035 12/31/2013 TRANSONIC HCM 103 SYSTEM TRANSONIC SYSTEMS, INC.
K134051 12/31/2013 TRANSONIC ELSA SYSTEM TRANSONIC SYSTEMS, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact