Device Classification Name |
Computer, Blood-Pressure
|
510(k) Number |
K871718 |
Device Name |
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER |
Applicant |
A & D ENGINEERING, INC. |
P.O. BOX 32427 |
SAN JOSE,
CA
95152
|
|
Applicant Contact |
KIMIO SHIBATA |
Correspondent |
A & D ENGINEERING, INC. |
P.O. BOX 32427 |
SAN JOSE,
CA
95152
|
|
Correspondent Contact |
KIMIO SHIBATA |
Regulation Number | 870.1110 |
Classification Product Code |
|
Date Received | 05/04/1987 |
Decision Date | 06/24/1987 |
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
|
|
|