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FDA 510(k)

audifon Tinnitus-Module

K-Number: K171243 · 2017-10-19

ApplicantAudiofon USA, Inc.
Decision Date2017-10-19
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

audifon Tinnitus-Module is the device name listed in this FDA 510(k) record. The listed applicant is Audiofon USA, Inc.. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K171243. 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 audifon Tinnitus-Module?

audifon Tinnitus-Module is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Audiofon USA, Inc.. The 510(k) number is K171243.

When did audifon Tinnitus-Module receive FDA 510(k) clearance?

audifon Tinnitus-Module received FDA 510(k) clearance on 2017-10-19, under 510(k) number K171243.

Who is the listed applicant for audifon Tinnitus-Module?

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

What is the FDA product code for audifon Tinnitus-Module?

The FDA product code for audifon Tinnitus-Module 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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