EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE— 510(k) K093715

Name: FDA 510(k) clearance K093715
Creator: U.S. Food and Drug Administration
Published: 2010-12-22

Substantially Equivalent

Magnatone Hearing Aid Corp. Dba Persona Medical

FDA 510(k) clearance K093715 for EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE, Substantially Equivalent on 2010-12-22. Applicant: Magnatone Hearing Aid Corp. Dba Persona Medical. Device class: 2.

Clearance details

Applicant: Magnatone Hearing Aid Corp. Dba Persona Medical
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2009-12-01
Decision date: 2010-12-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Casselberry, FL, 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.