Device Classification Name |
Audiometer
|
510(k) Number |
K890497 |
Device Name |
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER |
Applicant |
MONITOR/DEMLAR |
437 DIMMOCKS MILL RD. |
HILLSBOROUGH,
NC
27278
|
|
Applicant Contact |
MACK J PRESLAR |
Correspondent |
MONITOR/DEMLAR |
437 DIMMOCKS MILL RD. |
HILLSBOROUGH,
NC
27278
|
|
Correspondent Contact |
MACK J PRESLAR |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 02/01/1989 |
Decision Date | 06/06/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|