| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K870049 |
| Device Name |
EMT-102 CARDIAC MONITOR |
| Applicant |
| Evergreen Medical Technologies, Inc. |
| 14968 NW Greenbrier Pkwy. |
|
Beaverton,
OR
97006
|
|
| Applicant Contact |
CHARLES L DAVIS |
| Correspondent |
| Evergreen Medical Technologies, Inc. |
| 14968 NW Greenbrier Pkwy. |
|
Beaverton,
OR
97006
|
|
| Correspondent Contact |
CHARLES L DAVIS |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 01/06/1987 |
| Decision Date | 04/22/1987 |
| 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
|
|
|