Data analysis software 3.4

GUDID 06430056480022

A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®.

Elekta Oy

Electroencephalograph
Primary Device ID06430056480022
NIH Device Record Keyd6889373-2161-403e-9729-171506c75e61
Commercial Distribution StatusIn Commercial Distribution
Brand NameData analysis software 3.4
Version Model NumberSW23380N
Company DUNS538025107
Company NameElekta Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430056480022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Elekta Oy

06430056480008 - Elekta Neuromag® TRIUX2018-07-06 The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalo
06430056480015 - Elekta Neuromag® TRIUX2018-07-06 The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalo
06430056480022 - Data analysis software 3.42018-07-06A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®.
06430056480022 - Data analysis software 3.42018-07-06 A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®.
06430056480046 - Elekta Neuromag ® Data Analysis Software MaxFilter2018-07-06
06430056480053 - Patient chair2018-07-06 Adjustable patient chair with accessories for comfortable seated measurement position.
06430056480060 - Patient couch 2018-07-06 Patient couch for the supine measurement position.
06430056480077 - Child insert for chair2018-07-06 A booster seat and neck collar for pediatric patients.
06430056480084 - Auditory stimulator (earphones)2018-07-06 A binaural auditory stimulator for eliciting auditory evoked fields.

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