FDA.report

510(k) K221125

Device
SilentCloud
Applicant
Aureliym GmbH
510(k) number
K221125
Product code
KLW
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-04
Date received
2022-04-18
Regulation
874.3400
Classification name
Masker, Tinnitus
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
Markus Haller
Address
Hauptstrasse 96 Bad Neuenahr-Ahrweiler DE D-53474 D-53474

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KLW

510(k)DeviceApplicantDecision date
K233435Peace N Quiet (0.7.0)Pnq Health2024-02-27
K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB2023-06-30
K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.2023-02-01
K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.2020-06-19
K193303Tinnitus Sound Generator ModuleGN Hearing A/S2020-02-20
K180495Tinnitus Sound Generator ModuleGN Hearing A/S2018-11-30
K181586Tinnitus Sound Generator ModuleGN Hearing A/S2018-07-13
K171243audifon Tinnitus-ModuleAudiofon USA, Inc.2017-10-19
K163094TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd.2017-05-17
K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc.2016-09-28
K161331HyperSound Tinnitus ModuleTurtle Beach Corporation2016-08-23
K151558Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro SystemNeurotherapies Reset GmbH2016-01-20
K151719REVE134Kw Ear Lab, Inc.2015-10-09
K150014SerenitySanuthera, Inc.2015-07-27
K150171Tinnitus Sound Generator ModuleGn Resound A/S2015-05-14