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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K170441
Device Name ElectroTek
Applicant
Mobilemedtek
1205 E. Washington St., Suite 115
Louisville,  KY  40206
Applicant Contact Bryan Ehret
Correspondent
Mobilemedtek
1205 E. Washington St., Suite 115
Louisville,  KY  40206
Correspondent Contact Bryan Ehret
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GWL  
Date Received02/14/2017
Decision Date 06/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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