Lifelines iEEG Client Software - Lifelines iEEG is software system used to manage - Kvikna Medical ehf.

Duns Number:500793540

Device Description: Lifelines iEEG is software system used to manage and review EEG examinations. It works on Lifelines iEEG is software system used to manage and review EEG examinations. It works on dataacquired by third party EEG equipment that is imported into the system. The EEG is presented in aconventional way and conventional signal processing is applied such as re-montaging and band passfiltering. The system is also capable of presenting digital video synchronized to the EEG if this isavailable. 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 dataover WAN without the use of additional remote desktop software solutions. The two main componentsof Lifelines iEEG are iEEG Centrum and iEEC Review.

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More Product Details

Catalog Number

-

Brand Name

Lifelines iEEG Client Software

Version/Model Number

KSW2050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 15, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123665

Product Code Details

Product Code

OLT

Product Code Name

Non-Normalizing Quantitative Electroencephalograph Software

Device Record Status

Public Device Record Key

133d5e29-cf9a-48eb-9716-978873a388f6

Public Version Date

January 15, 2021

Public Version Number

6

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KVIKNA MEDICAL EHF." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14