Device Classification Name |
Stimulator, Auditory, Evoked Response
|
510(k) Number |
K122067 |
Device Name |
TYPE 1077 ACCUSCREEN |
Applicant |
GN OTOMETRICS |
HOERSKAETTEN 9 |
TAATRUP,
DK
DK-2630
|
|
Applicant Contact |
TOM RINIKER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
PAULA WILKERSON |
Regulation Number | 882.1900
|
Classification Product Code |
|
Date Received | 07/16/2012 |
Decision Date | 09/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|