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510(k) K904294

Device
QSI 9500
Applicant
QUANTIFIED SIGNAL IMAGING, INC.
510(k) number
K904294
Product code
OLU  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-30
Date received
1990-09-19
Regulation
882.1400
Classification name
Normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HOWARD GALIN
Address
290 Yorkland Blvd. Toronto CA M2J 1R5 M2J 1R5

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OLU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240420NeuroField Analysis SuiteNeurofield, Inc.2024-09-20
K222838iSyncBrain©-CiMediSync, Inc.2023-03-16
K212684BrainView QEEG SoftwareMedeia, Inc.2023-01-28
K202588BNA PlatformElminda, Ltd.2020-12-07
K191432cortiQ PROG.Tec Medical Engineering GmbH2020-01-24
K171414qEEG-ProBrainmaster Technologies, Inc.2018-07-01
K121119BNA ANALYSIS SYSTEMEiminda , Ltd.2014-07-25
K112077HBIDB - HUMAN BRIAN INDEX SOFTWARECorscience GmbH & Co. KG2012-03-09
K050192BRC SOFTWARE PRODUCTBrc Operations Pty Limited2005-10-20
K041263NEUROGUIDE ANALYSIS SYSTEMApplied Neuroscience, Inc.2004-08-03
K974748NEUROMETRIC ANALYSIS SYSTEMNxlink, Ltd.1998-07-10

Legacy Summary#

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FDA Review#

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