TinniLogic Mobile Tinnitus Management Device— 510(k) K163094

Name: FDA 510(k) clearance K163094
Creator: U.S. Food and Drug Administration
Published: 2017-05-17

Substantially Equivalent

Jiangsu Betterlife Medical Co., Ltd.

FDA 510(k) clearance K163094 for TinniLogic Mobile Tinnitus Management Device, Substantially Equivalent on 2017-05-17. Applicant: Jiangsu Betterlife Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jiangsu Betterlife Medical Co., Ltd.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2016-11-04
Decision date: 2017-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changshu, CN

Download summary PDF View on FDA.gov ↗

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