SoundCure Serenade Tinnitus Treatment System— 510(k) K150065

Name: FDA 510(k) clearance K150065
Creator: U.S. Food and Drug Administration
Published: 2015-04-13

Substantially Equivalent

Soundcure, Inc.

FDA 510(k) clearance K150065 for SoundCure Serenade Tinnitus Treatment System, Substantially Equivalent on 2015-04-13. Applicant: Soundcure, Inc.. Device class: 2.

Clearance details

Applicant: Soundcure, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2015-01-13
Decision date: 2015-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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