Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K180495 |
Device Name |
Tinnitus Sound Generator Module |
Applicant |
GN Hearing A/S |
Lautrupbjerg 7 |
Ballerup,
DK
2750
|
|
Applicant Contact |
Lars Hagander |
Correspondent |
GN Hearing A/S |
Lautrupbjerg 7 |
Ballerup,
DK
2750
|
|
Correspondent Contact |
Lars Hagander |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 02/26/2018 |
Decision Date | 11/30/2018 |
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
|
|
|