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510(k) K151558

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System by Neurotherapies Reset GmbH — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2016
Date Received
June 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type

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