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510(k) K232210

Device
X-trodes System M
Applicant
X-Trodes
510(k) number
K232210
Product code
GWL
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-04
Date received
2023-07-26
Regulation
882.1835
Classification name
Amplifier, Physiological Signal
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ziv Peremen
Address
7 Sapir St. Herzeliya IL 4685211 4685211

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K2017478-CH Electroencephalography AmplifierHipposcreen Neurotech Corp.2020-12-27
K172312eego amplifiersEemagine Medical Imaging Solutions GmbH2018-03-30
K171397Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H.2017-10-06
K171669g.Nautilus PROG.Tec Medical Engineering GmbH2017-07-05
K151600R-40 EEG AmplifierLifelines , Ltd.2015-10-23
K133517NEMUS 2 SYSTEMEb Neuro S.P.A.2014-02-26