Lifelines iEEG Server Software

GUDID 05694110063069

Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported

Kvikna Medical ehf.

Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software
Primary Device ID05694110063069
NIH Device Record Keycfc06474-3225-471d-b9e4-e5ed2cb20254
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifelines iEEG Server Software
Version Model NumberKSW2060
Company DUNS500793540
Company NameKvikna Medical ehf.
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 Batchfalse
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
GS105694110063069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLTNon-Normalizing Quantitative Electroencephalograph Software

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 Date2016-10-03

Devices Manufactured by Kvikna Medical ehf.

05694110068057 - Stratus EEG2021-02-05 Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipmen
05694110068064 - Stratus EEG2021-02-05 Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipmen
05694110068071 - Stratus EEG2021-02-05 The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological da
05694110068040 - Stratus EEG2020-09-09 Stratus EEG Web is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equi
05694110063007 - Lifelines iEEG Portable Yoga Tablet Wired2018-07-06 The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital
05694110063014 - Lifelines iEEG Portable Yoga Tablet Wireless2018-07-06 The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital
05694110063021 - Lifelines iEEG Portable Laptop System Wired2018-07-06 The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital
05694110063038 - Lifelines iEEG Portable Laptop System Wireless2018-07-06 The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital

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