| 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
|
|
|