Lifelines IEEG
Non-normalizing Quantitative Electroencephalograph Software
KVIKNA EHF
The following data is part of a premarket notification filed by Kvikna Ehf with the FDA for Lifelines Ieeg.
Pre-market Notification Details
| Device ID | K143487 |
| 510k Number | K143487 |
| Device Name: | Lifelines IEEG |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | KVIKNA EHF STORHOFOI 21 Reykjavik, IS 110 |
| Contact | Gardar Thorvardsson |
| Correspondent | Yolanda Smith Smith Assoicates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-08 |
| Decision Date | 2015-08-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05694110063090 | K143487 | 000 |
| 05694110063083 | K143487 | 000 |
| 05694110063076 | K143487 | 000 |
| 05694110063045 | K143487 | 000 |
| 05694110063038 | K143487 | 000 |
| 05694110063021 | K143487 | 000 |
| 05694110063014 | K143487 | 000 |
| 05694110063007 | K143487 | 000 |
| 05694110068071 | K143487 | 000 |
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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