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510(k) K163094

TinniLogic Mobile Tinnitus Management Device by Jiangsu Betterlife Medical Co., Ltd. — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2017
Date Received
November 4, 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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