| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FDA 510(k) Applications for Medical Device Product Code "JAF"
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| K242487 | Laminar Digital Health, Inc. | Laminar P1 (LDH-HW-001) | 12/13/2024 |
| 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 |