| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K852795 |
| Device Name |
SUNBEAM HEALTH MONITOR MODEL NO. 7600 |
| Applicant |
| Aanson Scale Co. |
| P.O. Box 38 |
|
Shubuta,
MS
39360
|
|
| Applicant Contact |
ROY A BROWN |
| Correspondent |
| Aanson Scale Co. |
| P.O. Box 38 |
|
Shubuta,
MS
39360
|
|
| Correspondent Contact |
ROY A BROWN |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 07/01/1985 |
| Decision Date | 11/18/1985 |
| 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
|
|
|