| Device Classification Name |
Stethoscope, Electronic
|
| 510(k) Number |
K893557 |
| Device Name |
ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING) |
| Applicant |
| Medical Monitors, Inc. |
| 3007 Alabama Ave. N. |
|
Fort Payne,
AL
35967
|
|
| Applicant Contact |
GLYNN W ODOM |
| Correspondent |
| Medical Monitors, Inc. |
| 3007 Alabama Ave. N. |
|
Fort Payne,
AL
35967
|
|
| Correspondent Contact |
GLYNN W ODOM |
| Regulation Number | 870.1875 |
| Classification Product Code |
|
| Date Received | 05/08/1989 |
| Decision Date | 03/19/1990 |
| 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
|
|
|