SoundCure Serenade Tinnitus Treatment System

FDA 510(k) K150065 · Soundcure, Inc.

Substantially Equivalent

510(k) numberK150065

Submission

Device name
SoundCure Serenade Tinnitus Treatment System
Applicant
Soundcure, Inc.
San Jose, CA, US
Received
January 13, 2015
Decision date
April 13, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KLW – Masker, Tinnitus
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3400
Specialty
Ear, Nose, Throat

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Questions and answers

When was SoundCure Serenade Tinnitus Treatment System cleared by the FDA?

SoundCure Serenade Tinnitus Treatment System (K150065) received a 510(k) decision of Substantially Equivalent on April 13, 2015, 90 days after the submission was received.

What is the product code of K150065?

The FDA product code is KLW – Masker, Tinnitus, a Class II (moderate risk) device regulated under 21 CFR 874.3400.