Device Classification Name |
Devices, Breath Trapping, Alcohol
|
510(k) Number |
K160613 |
Device Name |
Soberlink Cellular Device and Sober Sky Web Portal |
Applicant |
SOBERLINK HEALTHCARE LLC |
16787 BEACH BLVD #211 |
HUNTINGTON BEACH,
CA
92647
|
|
Applicant Contact |
JENNA COSTA |
Correspondent |
OBELIX CONSULTING LLC |
12416 FAIRFAX RIDGE PLACE |
AUSTIN,
TX
78738
|
|
Correspondent Contact |
ELISA MALDONADO-HOLMERTZ |
Regulation Number | 862.3050
|
Classification Product Code |
|
Date Received | 03/03/2016 |
Decision Date | 07/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02544581 NCT02650180
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|