| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K871794 |
| Device Name |
EASY READ(TM) |
| Applicant |
| Health O Meter |
| 7400 W 100th Pl. |
|
Bridgeview,
IL
60455
|
|
| Applicant Contact |
ALAN J RABIN |
| Correspondent |
| Health O Meter |
| 7400 W 100th Pl. |
|
Bridgeview,
IL
60455
|
|
| Correspondent Contact |
ALAN J RABIN |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 05/07/1987 |
| Decision Date | 06/19/1987 |
| 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
|
|
|