Device Classification Name |
Audiometer
|
510(k) Number |
K011135 |
Device Name |
GSI AUDERA |
Applicant |
NICOLET BIOMEDICAL |
6355 JOYCE DR. |
GOLDEN,
CO
80403
|
|
Applicant Contact |
DAVID W WAGNER |
Correspondent |
NICOLET BIOMEDICAL |
6355 JOYCE DR. |
GOLDEN,
CO
80403
|
|
Correspondent Contact |
DAVID W WAGNER |
Regulation Number | 874.1050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/13/2001 |
Decision Date | 07/26/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|