Device Classification Name |
masker, tinnitus
|
510(k) Number |
K221168 |
Device Name |
Tinnitogram Signal Generator |
Applicant |
Goldenear Company, Inc. |
24207 Via Perla |
Santa Clarita,
CA
91354
|
|
Applicant Contact |
Daehee Lee |
Correspondent |
Goldenear Company, Inc. |
24207 Via Perla |
Santa Clarita,
CA
91354
|
|
Correspondent Contact |
Daehee Lee |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 04/22/2022 |
Decision Date | 02/01/2023 |
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
|
|
|