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 Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system| 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 |
Trademark Results [Lifelines iEEG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIFELINES IEEG 86293754 5241811 Live/Registered |
Kvikna ehf. 2014-05-28 |
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