510(k) K143487— Lifelines iEEG

Substantially Equivalent

Kvikna Ehf

Clearance details

Applicant: Kvikna Ehf
Product code: Code OLT
Advisory panel: Neurology
Date received: 2014-12-08
Decision date: 2015-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reykjavik, IS

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.