Stratus EEG

GUDID 05694110068071

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.

Kvikna Medical ehf.

Bioelectrical signal analysis software

• Primary Device ID: 05694110068071
• NIH Device Record Key: a90a140d-9f2f-4176-9b9d-2bd08459ebc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratus EEG
• 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: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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 [Previous]
GS1	05694110068071 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-05
• Device Publish Date: 2021-01-28

On-Brand Devices [Stratus EEG]

• 05694110068040: Stratus EEG Web is software system used to manage and review EEG examinations. It works on data
• 05694110068071: The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review o
• 05694110068064: Stratus EEG is software system used to manage and review EEG examinations. It works on data acqu
• 05694110068057: Stratus EEG is software system used to manage and review EEG examinations. It works on data acqu