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510(k) K161331

HyperSound Tinnitus Module by Turtle Beach Corporation — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2016
Date Received
May 12, 2016
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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