Tinnitogram Signal Generator
K-Number: K221168 · 2023-02-01
ApplicantGoldenear Company, Inc.
Decision Date2023-02-01
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Tinnitogram Signal Generator is a medical device manufactured by Goldenear Company, Inc.. It received FDA 510(k) clearance on 2023-02-01 under approval number K221168. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tinnitogram Signal Generator?
Tinnitogram Signal Generator is a medical device that received FDA 510(k) clearance on 2023-02-01. It is manufactured by Goldenear Company, Inc.. The 510(k) number is K221168.
When was Tinnitogram Signal Generator approved by the FDA?
Tinnitogram Signal Generator received FDA 510(k) clearance on 2023-02-01, under approval number K221168.
What company makes Tinnitogram Signal Generator?
Tinnitogram Signal Generator is manufactured by Goldenear Company, Inc..
What is the FDA product code for Tinnitogram Signal Generator?
The FDA product code for Tinnitogram Signal Generator is KLW.
Related Clinical Trials
Related Devices (Code: KLW)
K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc.
K161331HyperSound Tinnitus ModuleTurtle Beach Corporation
K151558Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro SystemNeurotherapies Reset GmbH
K171243audifon Tinnitus-ModuleAudiofon USA, Inc.
K163094TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd.
K180495Tinnitus Sound Generator ModuleGN Hearing A/S
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.