Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K912119 |
Device Name |
DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212 |
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 | 05/14/1991 |
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
|
|
|