| 510(k) Number |
K837085 |
| Device Name |
DOPPLER FOR DETECTING OCCLUSIONS AND TAKING SYSTOLIC BLOOD PRESSURE |
| Applicant |
| E.M. Adams |
| 121 W. St. |
|
Medfield,
MA
02052
|
|
| Correspondent |
| E.M. Adams |
| 121 W. St. |
|
Medfield,
MA
02052
|
|
| Date Received | 04/12/1983 |
| Decision Date | 05/09/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|