Lifelines iEEG— 510(k) K143487

Name: FDA 510(k) clearance K143487
Creator: U.S. Food and Drug Administration
Published: 2015-08-21

Substantially Equivalent

Kvikna Ehf

FDA 510(k) clearance K143487 for Lifelines iEEG, Substantially Equivalent on 2015-08-21. 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: 2014-12-08
Decision date: 2015-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reykjavik, IS

Download summary PDF View on FDA.gov ↗

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K123665 — LIFELINES IEEG2013-03-25

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.