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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K122040
Device Name INVOTEC LARYNGEAL ELECTRODE
Applicant
Invotec International, Inc.
6833 Phillips Industrial Blvd.
Jacksonville,  FL  32256
Applicant Contact JEFFREY L AULL
Correspondent
Invotec International, Inc.
6833 Phillips Industrial Blvd.
Jacksonville,  FL  32256
Correspondent Contact JEFFREY L AULL
Regulation Number874.1820
Classification Product Code
ETN  
Date Received07/12/2012
Decision Date 10/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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