Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System— 510(k) K151558

Name: FDA 510(k) clearance K151558
Creator: U.S. Food and Drug Administration
Published: 2016-01-20

Substantially Equivalent

Neurotherapies Reset GmbH

FDA 510(k) clearance K151558 for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System, Substantially Equivalent on 2016-01-20. Applicant: Neurotherapies Reset GmbH. Device class: 2.

Clearance details

Applicant: Neurotherapies Reset GmbH
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2015-06-10
Decision date: 2016-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Juelich, DE

Download summary PDF View on FDA.gov ↗

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