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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K133995
Device Name NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
Applicant
Neurosoft , Ltd.
Via Marzia N. 9
Abano Terme, Padova,  IT 35031
Applicant Contact ENRICO BISSON
Correspondent
Neurosoft , Ltd.
Via Marzia N. 9
Abano Terme, Padova,  IT 35031
Correspondent Contact ENRICO BISSON
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWQ   OLV  
Date Received12/26/2013
Decision Date 06/19/2015
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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