Lifelines iEEG

GUDID 05694110063090

The Lifelines iEEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video sy

Kvikna Medical ehf.

Electroencephalographic monitoring system, portable

• Primary Device ID: 05694110063090
• NIH Device Record Key: 0d781276-a66a-471b-8274-46971c75eb6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lifelines iEEG
• Version Model Number: Acquisition
• Company DUNS: 500793540
• Company Name: Kvikna Medical ehf.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05694110063090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143487

FDA Product Code

• OLT: Non-Normalizing Quantitative Electroencephalograph Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-09

Devices Manufactured by Kvikna Medical ehf.

• 05694110068057 - Stratus EEG: 2021-02-05 Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipmen
• 05694110068064 - Stratus EEG: 2021-02-05 Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipmen
• 05694110068071 - Stratus EEG: 2021-02-05 The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological da
• 05694110068040 - Stratus EEG: 2020-09-09 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 Wired: 2018-07-06 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 Wireless: 2018-07-06 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 Wired: 2018-07-06 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 Wireless: 2018-07-06 The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital