Lifelines iEEG Portable Yoga Tablet Wired

GUDID 05694110063007

The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to

Kvikna Medical ehf.

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph
Primary Device ID05694110063007
NIH Device Record Key3146b922-d385-45c0-8e7a-0d0adb020a1e
Commercial Distribution Discontinuation2018-01-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLifelines iEEG Portable Yoga Tablet Wired
Version Model NumberKHW1020
Company DUNS500793540
Company NameKvikna Medical ehf.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS105694110063007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

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 Date2016-08-18

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