E-EEGX, N-EEGX— 510(k) K191322

Name: FDA 510(k) clearance K191322
Creator: U.S. Food and Drug Administration
Published: 2020-01-22

Substantially Equivalent

GE Healthcare Finland Oy

FDA 510(k) clearance K191322 for E-EEGX, N-EEGX, Substantially Equivalent on 2020-01-22. Applicant: GE Healthcare Finland Oy. Device class: 2.

Clearance details

Applicant: GE Healthcare Finland Oy
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2019-05-15
Decision date: 2020-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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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.