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 | K123665 |
| 510k Number | K123665 |
| Device Name: | LIFELINES IEEG |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | KVIKNA EHF 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith KVIKNA EHF 1468 HARWELL AVE 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 | 2012-11-28 |
| Decision Date | 2013-03-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05694110063069 | K123665 | 000 |
| 05694110063052 | K123665 | 000 |
| 05694110068040 | K123665 | 000 |
| 05694110068064 | K123665 | 000 |
| 05694110068057 | K123665 | 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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