Device Classification Name |
masker, tinnitus
|
510(k) Number |
K223694 |
Device Name |
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) |
Applicant |
Duearity AB |
Krusegrand 42d |
Malmo,
SE
21225
|
|
Applicant Contact |
Anneli Johansson |
Correspondent |
Duearity AB |
Krusegrand 42d |
Malmo,
SE
21225
|
|
Correspondent Contact |
Anneli Johansson |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 12/09/2022 |
Decision Date | 06/30/2023 |
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
|
|
|