Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K221125 |
Device Name |
SilentCloud |
Applicant |
Aureliym GmBH |
Hauptstrasse 96 |
Bad Neuenahr-Ahrweiler,
DE
D-53474
|
|
Applicant Contact |
Markus Haller |
Correspondent |
Aureliym GmBH |
Hauptstrasse 96 |
Bad Neuenahr-Ahrweiler,
DE
D-53474
|
|
Correspondent Contact |
Markus Haller |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 04/18/2022 |
Decision Date | 01/04/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|