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FDA 510(k)

Sound Options Tinnitus Treatment

K-Number: K161562 · 2016-09-28

ApplicantSound Options Tinnitus Treatments, Inc.
Decision Date2016-09-28
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sound Options Tinnitus Treatment is the device name listed in this FDA 510(k) record. The listed applicant is Sound Options Tinnitus Treatments, Inc.. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K161562. 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 Sound Options Tinnitus Treatment?

Sound Options Tinnitus Treatment is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Sound Options Tinnitus Treatments, Inc.. The 510(k) number is K161562.

When did Sound Options Tinnitus Treatment receive FDA 510(k) clearance?

Sound Options Tinnitus Treatment received FDA 510(k) clearance on 2016-09-28, under 510(k) number K161562.

Who is the listed applicant for Sound Options Tinnitus Treatment?

The FDA 510(k) record lists Sound Options Tinnitus Treatments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sound Options Tinnitus Treatment?

The FDA product code for Sound Options Tinnitus Treatment 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 ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

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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