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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K093715
Device Name EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
Applicant
Magnatone Hearing Aid Corp. Dba Persona Medical
170 N. Cypress Way
Casselberry,  FL  32707
Applicant Contact DON CAMPBELL
Correspondent
Magnatone Hearing Aid Corp. Dba Persona Medical
170 N. Cypress Way
Casselberry,  FL  32707
Correspondent Contact DON CAMPBELL
Regulation Number874.3400
Classification Product Code
KLW  
Date Received12/01/2009
Decision Date 12/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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