Device Classification Name |
Audiometer
|
510(k) Number |
K981460 |
Device Name |
CUB DIS II DPOAE MEASUREMENT SYSTEM |
Applicant |
MIMOSA ACOUSTICS, INC. |
382 FOREST HILL WAY |
MOUNTAINSIDE,
NJ
07092
|
|
Applicant Contact |
PATRICIA S JENG |
Correspondent |
MIMOSA ACOUSTICS, INC. |
382 FOREST HILL WAY |
MOUNTAINSIDE,
NJ
07092
|
|
Correspondent Contact |
PATRICIA S JENG |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 04/23/1998 |
Decision Date | 05/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|