SoundCure Serenade Tinnitus Treatment System— 510(k) K150065

Substantially Equivalent

Soundcure, Inc.

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

Clearance details

Applicant: Soundcure, Inc.
Product code: Code KLW
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

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