FDA.reportPublic FDA data

Stratus EEG

Primary DI
05694110068071
Brand
Stratus EEG
Company
Kvikna Medical ehf.
Model
Acquisition
Device description
The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Published
2021-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OLTNon-Normalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143487000Lifelines iEEGKvikna Ehf2015-08-21OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694110063090PreviousGS10
05694110068071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694110063090056941100630905694110063090
05694110068071056941100680715694110068071

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
500793540
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05694110063007Lifelines iEEG Portable Yoga Tablet WiredKHW10202016-08-18
05694110063014Lifelines iEEG Portable Yoga Tablet WirelessKHW10222016-08-18
05694110063021Lifelines iEEG Portable Laptop System WiredKHW10102016-08-18
05694110063038Lifelines iEEG Portable Laptop System WirelessKHW10302016-08-18
05694110063045Lifelines iEEG Portable Laptop System No VideoKHW10402016-08-18
05694110063076Lifelines iEEG Portable Yoga Tablet No VideoKHW10502016-10-03
05694110063083Lifelines iEEG Clinical Desktop SystemKHW2050 2017-05-04
05694110063090Lifelines iEEGAcquisition 2017-11-09
05694110068057Stratus EEGServer Software2021-01-28
05694110068064Stratus EEGClient Software2021-01-28
05694110063052Lifelines iEEG Client SoftwareKSW20502016-10-03
05694110063069Lifelines iEEG Server SoftwareKSW20602016-10-03
05694110068040Stratus EEGWeb2020-09-01

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