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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K131415
Device Name LIVE VIEW PANEL (LVP)
Applicant
Neurotronics, Inc.
3600 NW 43rd St., Suite F1
Gainesville,  FL  32606
Applicant Contact DAVID PEZET
Correspondent
Neurotronics, Inc.
3600 NW 43rd St., Suite F1
Gainesville,  FL  32606
Correspondent Contact DAVID PEZET
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Codes
GWQ   OLT   OLZ  
Date Received05/16/2013
Decision Date 08/09/2013
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
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