Device Classification Name |
devices, breath trapping, alcohol
|
510(k) Number |
K093143 |
Device Name |
MISSION BREATH ALCOHOL DETECTOR |
Applicant |
ACON LABORATORIES, INC. |
10125 MESA RIM RD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
RICHARD LENART |
Correspondent |
ACON LABORATORIES, INC. |
10125 MESA RIM RD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
RICHARD LENART |
Regulation Number | 862.3050
|
Classification Product Code |
|
Date Received | 10/05/2009 |
Decision Date | 01/28/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|