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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
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