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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 K121257
Device Name LARYNGEAL ELECTRODE
Applicant
TECHNOMED EUROPE
amerikalaan 71
maastricht airport, 
Contact pierre vreuls
Regulation Number874.1820
Classification Product Code
ETN  
Date Received04/26/2012
Decision Date 08/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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