UNITRON TINNITUS MASKER FEATURE— 510(k) K130494

Name: FDA 510(k) clearance K130494
Creator: U.S. Food and Drug Administration
Published: 2013-05-07

Substantially Equivalent

Unitron Hearing

FDA 510(k) clearance K130494 for UNITRON TINNITUS MASKER FEATURE, Substantially Equivalent on 2013-05-07. Applicant: Unitron Hearing. Device class: 2.

Clearance details

Applicant: Unitron Hearing
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2013-02-26
Decision date: 2013-05-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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