FDA 510(k) Applications for Medical Device Product Code "JAF"
(Monitor, Ultrasonic, Nonfetal)

FDA 510(k) Number Applicant Device Name Decision Date
K973644 BIOMEDIX, INC. FLOSTAT VASCULAR LAB 12/23/1997
K973857 BIOMEDIX, INC. FLOSTAT VASCULAR REPORT GENERATOR (VRG) 12/29/1997
K943338 BIOSENSOR CORP. BIOSENSOR BIDOP VASCULAR TEST SYSTEM 04/12/1996
K070815 G.F. S.R.L. THD 06/20/2007
K973336 IMEX MEDICAL SYSTEMS, INC. IMEX STETHODOP 02/05/1998
K052067 MULTIGON INDUSTRIES, INC. DOPPLER GUIDED PROCTOSCOPE, MODEL 500H 08/29/2005
K110628 NEWMAN MEDICAL SIMPLEABI 05/12/2011
K982635 NICOLET BIOMEDICAL CAREDOP II 08/07/1998
K010521 NICOLET BIOMEDICAL NICOLET VERSALAB 03/09/2001
K060064 ODVI STETHOFLUX 04/10/2006
K093393 SUMMIT DOPPLER SYSTEMS, INC. LIFEDOP MODEL 300ABI 12/24/2009
K063600 SUMMIT DOPPLER SYSTEMS, INC. VISTA AVS 12/19/2006
K141657 THD SPA THD REVOLUTION 02/24/2015
K081429 THD SPA THD SLIDE 07/30/2008
K090009 THD SPA THD SLIDE ONE 01/28/2009


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