Device Classification Name |
audiometer
|
510(k) Number |
K172403 |
Device Name |
GSI Novus |
Applicant |
Grason-Stadler Inc. |
10395 West 70th Street |
Eden Prairie,
MN
55344
|
|
Applicant Contact |
Amy Yanta |
Correspondent |
Grason-Stadler Inc. |
10395 West 70th Street |
Eden Prairie,
MN
55344
|
|
Correspondent Contact |
Amy Yanta |
Regulation Number | 874.1050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/09/2017 |
Decision Date | 10/20/2017 |
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
|
|
|