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510(k) K201910

Device
EZTrack
Applicant
Neurologic, LLC
510(k) number
K201910
Product code
OLX
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-22
Date received
2020-07-09
Regulation
882.1400
Classification name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sridevi Sarma
Address
6500 Tucker Ave. Mclean VA US 22101 22101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K041264ELEKTA OYElekta Neuromag OY2004-08-10
K040051MEGVISION, MODEL EQ1000C SERIESEagle Technology, Inc.2004-03-24
K030737OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275Ctf Systems (2001), Inc.2003-10-10