Device Classification Name |
audiometer
|
510(k) Number |
K123624 |
Device Name |
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM |
Applicant |
MIMOSA ACOUSTICS, INC. |
335 N Fremont St |
CHAMPAIGN,
IL
61820
|
|
Applicant Contact |
PATRICIA S JENG |
Correspondent |
MIMOSA ACOUSTICS, INC. |
335 N Fremont St |
CHAMPAIGN,
IL
61820
|
|
Correspondent Contact |
PATRICIA S JENG |
Regulation Number | 874.1050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/23/2012 |
Decision Date | 03/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|