Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K141160 |
Device Name |
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR |
Applicant |
A & D CO., LTD. |
1756 AUTOMATION PARKWAY |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
JERRY WANG |
Correspondent |
A & D CO., LTD. |
1756 AUTOMATION PARKWAY |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
JERRY WANG |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 05/05/2014 |
Decision Date | 10/07/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|