Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K960319 |
Device Name |
A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR |
Applicant |
A & D ENGINEERING, INC. |
1555 MC CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
JERRY WANG |
Correspondent |
A & D ENGINEERING, INC. |
1555 MC CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
JERRY WANG |
Regulation Number | 870.1130 |
Classification Product Code |
|
Date Received | 01/23/1996 |
Decision Date | 07/02/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|