LEVO TINNITUS MASKING SOFTWARE DEVICE— 510(k) K140845

Name: FDA 510(k) clearance K140845
Creator: U.S. Food and Drug Administration
Published: 2014-07-18

Substantially Equivalent

Otoharmonics Corp

FDA 510(k) clearance K140845 for LEVO TINNITUS MASKING SOFTWARE DEVICE, Substantially Equivalent on 2014-07-18. Applicant: Otoharmonics Corp. Device class: 2.

Clearance details

Applicant: Otoharmonics Corp
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2014-04-02
Decision date: 2014-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philedelphia, PA, 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.