FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K093143 |
ACON LABORATORIES, INC. |
MISSION BREATH ALCOHOL DETECTOR |
01/28/2010 |
K062971 |
Akers Biosciences, Inc. |
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS |
12/18/2006 |
K060761 |
Akers Biosciences, Inc. |
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS |
04/28/2006 |
K102338 |
Akers Biosciences, Inc. |
BREATHSCN PRO |
01/12/2011 |
K102225 |
ALCOPRO, INC. |
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST |
04/06/2011 |
K082080 |
ALCOTEST QUEBEC |
ALCO TUBE PLUS |
04/01/2009 |
K081855 |
CANADA, INC. |
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) |
12/19/2008 |
K052448 |
CONNECTABLES, LLC |
POCKET BREATHALYZER. CONNECTABLES |
02/23/2006 |
K100879 |
CONTRALCO |
CONTRALCO |
08/04/2010 |
K063443 |
DRAGER SAFETY |
DRAEGER ALCOTEST 6510 |
03/11/2008 |
K041334 |
KHN SOLUTIONS, LLC |
ALCOMATE, MODEL CA2000 |
08/11/2004 |
K071067 |
KHN SOLUTIONS, LLC |
BACTRACK LCD ALCOHOL DETECTOR |
09/14/2007 |
K090067 |
KHN SOLUTIONS, LLC |
BACTRACK SELECT BREATHALYZER, MODEL S80 |
03/24/2009 |
K083801 |
KHN SOLUTIONS, LLC |
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 |
03/19/2009 |
K090766 |
LIFELOC TECHNOLOGIES, INC. |
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER |
07/23/2009 |
K052804 |
OMEGAPOINT SYSTEMS, LLC |
BREATHKEY MODEL G10/BREATHKEY MODEL G30X |
12/09/2005 |
K123470 |
PAS SYSTEMS INTERNATIONAL, INC. |
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE |
04/29/2013 |
K080848 |
Q3 INNOVATIONS, LLC |
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR |
07/25/2008 |
K043188 |
Q3 INNOVATIONS, LLC |
ALCOHAWK PRECISION |
02/09/2005 |
K072953 |
REDLINE PRODUCTS (PTY) LTD. |
REDLINE ALCOHOL BREATH TESTER |
01/07/2008 |
K062545 |
RESOURCE MANAGEMENT INTERNATIONAL, LLC |
RMI LCD ALCOHOL DETECTOR |
04/09/2007 |
K110614 |
SEJU ENGINEERING CO., LTD. |
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM |
11/21/2011 |
K053332 |
SENTECH KOREA CORP. |
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 |
01/20/2006 |
K061922 |
SENTECH KOREA CORP. |
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 |
10/30/2006 |
K060343 |
SENTECH KOREA CORP. |
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 |
05/11/2006 |
K091714 |
SKYFINE INC. LIMITED |
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 |
11/18/2009 |
K160613 |
SOBERLINK HEALTHCARE LLC |
Soberlink Cellular Device and Sober Sky Web Portal |
07/14/2016 |
K082086 |
THE ASHLEY COLLECTION, INC. |
KEY RING ALCOHOL BREATHALYZER |
12/19/2008 |