Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K911049 |
Device Name |
DIGITAL SPHYGMOIMANOMETER, MODEL UA-830 |
Applicant |
A & D ENGINEERING, INC. |
1555 MC CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
ALBERT J PINZA |
Correspondent |
A & D ENGINEERING, INC. |
1555 MC CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
ALBERT J PINZA |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 03/08/1991 |
Decision Date | 08/07/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|