|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
COMPUTERIZED LABOR MONITORING SYSTEM
|
BARNEV, LTD. |
DEN060006 |
K060028 |
01/30/2007 |
MAMMAPRINT
|
AGENDIA BV |
DEN070009 |
K062694 |
02/06/2007 |
TEPHAFLEX ABSORBABLE SUTURE
|
TEPHA, INC. |
DEN060003 |
K052225 |
02/08/2007 |
XPERT EV, MODEL GXEV-100N-10; GENEXPERT
|
CEPHEID |
DEN070004 |
K061062 |
03/16/2007 |
3M N95 HOME RESPIRATOR WITH FLUID RESIST
|
3M COMPANY |
DEN060009 |
K062070 |
05/08/2007 |
INRANGE REMOTE MEDICATION MANAGEMENT SYS
|
INRANGE SYSTEMS, INC. |
DEN060002 |
K051338 |
06/13/2007 |
BINAX NOW MALARIA TEST; MODEL 660-000, 6
|
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI |
DEN070006 |
K061542 |
06/13/2007 |
ID-TAG RESPIRATORY VIRAL PANEL
|
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
DEN070013 |
K063765 |
01/03/2008 |
ALLOMAP MOLECULAR EXPRESSION TESTING
|
XDX |
DEN080007 |
K073482 |
08/26/2008 |
NEUROSTAR TMS SYSTEM
|
NEURONETICS |
DEN070003 |
K061053 |
10/07/2008 |