Device Classification Name |
calibrator, hearing aid / earphone and analysis systems
|
510(k) Number |
K061104 |
Device Name |
SPEECHLINK 100 TYPE 1053 |
Applicant |
GN OTOMETRICS A/S |
DYBENDALSVAENGET 2 |
P.O. BOX 119 |
TAASTRUP,
DK
DK-2630
|
|
Applicant Contact |
PER PAPE THOMSEN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 04/20/2006 |
Decision Date | 05/03/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|