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FDA 510(k)

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System

K-Number: K151558 · 2016-01-20

ApplicantNeurotherapies Reset GmbH
Decision Date2016-01-20
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is the device name listed in this FDA 510(k) record. The listed applicant is Neurotherapies Reset GmbH. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K151558. 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 Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Neurotherapies Reset GmbH. The 510(k) number is K151558.

When did Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System receive FDA 510(k) clearance?

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K151558.

Who is the listed applicant for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

The FDA 510(k) record lists Neurotherapies Reset GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

The FDA product code for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System 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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