Device Classification Name |
Apparatus, Vestibular Analysis
|
510(k) Number |
K102364 |
Device Name |
NYDIAG 200 |
Applicant |
INTERACOUSTICS A/S |
DREJERVAENGET 8 |
ASSENS,
DK
DK-5610
|
|
Applicant Contact |
ERIK NIELSEN |
Correspondent |
INTERACOUSTICS A/S |
DREJERVAENGET 8 |
ASSENS,
DK
DK-5610
|
|
Correspondent Contact |
ERIK NIELSEN |
Classification Product Code |
|
Date Received | 08/20/2010 |
Decision Date | 12/23/2010 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|