FDA 510(k)

HyperSound Tinnitus Module

K-Number: K161331 · 2016-08-23

Decision Date2016-08-23

Product CodeKLW

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

HyperSound Tinnitus Module is the device name listed in this FDA 510(k) record. The listed applicant is Turtle Beach Corporation. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K161331. 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 HyperSound Tinnitus Module?

HyperSound Tinnitus Module is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is Turtle Beach Corporation. The 510(k) number is K161331.

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

HyperSound Tinnitus Module received FDA 510(k) clearance on 2016-08-23, under 510(k) number K161331.

Who is the listed applicant for HyperSound Tinnitus Module?

The FDA 510(k) record lists Turtle Beach Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HyperSound Tinnitus Module?

The FDA product code for HyperSound 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 Corporation K260614Tinnitus TherapySivantos GmbH K233435Peace N Quiet (0.7.0)Pnq Health K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.