LIFELINES IEEG— 510(k) K123665

Name: FDA 510(k) clearance K123665
Creator: U.S. Food and Drug Administration
Published: 2013-03-25

Substantially Equivalent

Kvikna Ehf

FDA 510(k) clearance K123665 for LIFELINES IEEG, Substantially Equivalent on 2013-03-25. Applicant: Kvikna Ehf. Device class: 2.

Clearance details

Applicant: Kvikna Ehf
Product code: Product code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2012-11-28
Decision date: 2013-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLT

view all

K261712 — Ceribell EEG Analysis Software2026-09-16
K254213 — Pascall Sensor Unit (PSU1)2026-08-19
K253767 — UB ERP System2026-06-30
K251881 — HippoMind (v1.0)2025-12-03
K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)2025-10-09

More clearances from Kvikna Ehf

view all

K143487 — Lifelines iEEG2015-08-21

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.