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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Goldenear Company, Inc.. It received FDA 510(k) clearance on 2023-02-01 under 510(k) 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. The listed applicant is Goldenear Company, Inc.. The 510(k) number is K221168.

When did Tinnitogram Signal Generator receive FDA 510(k) clearance?

Tinnitogram Signal Generator received FDA 510(k) clearance on 2023-02-01, under 510(k) number K221168.

Who is the listed applicant for Tinnitogram Signal Generator?

The FDA 510(k) record lists Goldenear Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tinnitogram Signal Generator?

The FDA product code for Tinnitogram Signal Generator is KLW.

Related Devices (Code: KLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221125SilentCloudAureliym GmbHK201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.

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.

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