| Device Classification Name |
Blood Pressure Cuff
|
| 510(k) Number |
K872144 |
| Device Name |
MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER |
| Applicant |
| Vestra-Subco, Inc. |
| 1401 N. 14th St. |
| P.O. Box 845 |
|
Temple,
TX
76501
|
|
| Applicant Contact |
SATISH BHALERAO |
| Correspondent |
| Vestra-Subco, Inc. |
| 1401 N. 14th St. |
| P.O. Box 845 |
|
Temple,
TX
76501
|
|
| Correspondent Contact |
SATISH BHALERAO |
| Regulation Number | 870.1120 |
| Classification Product Code |
|
| Date Received | 06/04/1987 |
| Decision Date | 07/29/1987 |
| 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
|
|
|