Device Classification Name |
Audiometer
|
510(k) Number |
K060539 |
Device Name |
DPOAE20 , ECLIPSE |
Applicant |
INTERACOUSTICS A/S, ASSENS |
7625 GOLDEN TRIANGLE DRIVE |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
DANIEL EGGAN |
Correspondent |
INTERACOUSTICS A/S, ASSENS |
7625 GOLDEN TRIANGLE DRIVE |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
DANIEL EGGAN |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 03/01/2006 |
Decision Date | 05/30/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|