Sound Options Tinnitus Treatment— 510(k) K161562

Name: FDA 510(k) clearance K161562
Creator: U.S. Food and Drug Administration
Published: 2016-09-28

Substantially Equivalent

Sound Options Tinnitus Treatments, Inc.

FDA 510(k) clearance K161562 for Sound Options Tinnitus Treatment, Substantially Equivalent on 2016-09-28. Applicant: Sound Options Tinnitus Treatments, Inc.. Device class: 2.

Clearance details

Applicant: Sound Options Tinnitus Treatments, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2016-06-06
Decision date: 2016-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.