| Device Classification Name |
Stethoscope, Electronic
|
| 510(k) Number |
K842705 |
| Device Name |
MX2 ELECTRONIC STETHOSCOPE |
| Applicant |
| Medmax, Inc. |
| 412 First St. Se |
|
Washington ,
DC
20003
|
|
| Applicant Contact |
EVELYN HATTEN |
| Correspondent |
| Medmax, Inc. |
| 412 First St. Se |
|
Washington ,
DC
20003
|
|
| Correspondent Contact |
EVELYN HATTEN |
| Regulation Number | 870.1875 |
| Classification Product Code |
|
| Date Received | 07/11/1984 |
| Decision Date | 01/23/1985 |
| 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
|
|
|