SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM— 510(k) K111293

Name: FDA 510(k) clearance K111293
Creator: U.S. Food and Drug Administration
Published: 2011-08-24

Substantially Equivalent

Soundcure, Inc.

FDA 510(k) clearance K111293 for SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM, Substantially Equivalent on 2011-08-24. 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: 2011-05-06
Decision date: 2011-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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