ECLIPSE VERSION 3.0

Non-normalizing Quantitative Electroencephalograph Software

STELLATE SYSTEMS

The following data is part of a premarket notification filed by Stellate Systems with the FDA for Eclipse Version 3.0.

Pre-market Notification Details

Device IDK955577
510k NumberK955577
Device Name:ECLIPSE VERSION 3.0
ClassificationNon-normalizing Quantitative Electroencephalograph Software
Applicant STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 505 WESTMOUNT, QUEBEC, Canada, H32 2n2,  CA
ContactGeorge Papagiannis
CorrespondentGeorge Papagiannis
STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 505 WESTMOUNT, QUEBEC, Canada, H32 2n2,  CA
Product CodeOLT  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-08
Decision Date1996-09-20

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