Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K170196 |
Device Name |
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor |
Applicant |
A&D Company, Ltd. |
1756 Automation Parkway |
san jose,
CA
95131
|
|
Applicant Contact |
jerry wang |
Correspondent |
A&D Company, Ltd. |
1756 Automation Parkway |
san jose,
CA
95131
|
|
Correspondent Contact |
jerry wang |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 01/23/2017 |
Decision Date | 05/17/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|