Device Classification Name |
audiometer
|
510(k) Number |
K081234 |
Device Name |
GN OTOMETRICS INSERT EARPHONES |
Applicant |
GN OTOMETRICS |
125 E. COMMERCE DRIVE |
SCHAUMBURG,
IL
60173
|
|
Applicant Contact |
DANIEL SANSONETTI |
Correspondent |
GN OTOMETRICS |
125 E. COMMERCE DRIVE |
SCHAUMBURG,
IL
60173
|
|
Correspondent Contact |
DANIEL SANSONETTI |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 05/01/2008 |
Decision Date | 07/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|