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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 a medical device manufactured by Audiofon USA, Inc.. It received FDA 510(k) clearance on 2017-10-19 under approval 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. It is manufactured by Audiofon USA, Inc.. The 510(k) number is K171243.

When was audifon Tinnitus-Module approved by the FDA?

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

What company makes audifon Tinnitus-Module?

audifon Tinnitus-Module is manufactured by Audiofon USA, Inc..

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

The FDA product code for audifon Tinnitus-Module is KLW.

Related Devices (Code: KLW)

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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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