510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191322Substantially Equivalent

E-Eegx, N-Eegx

GE Healthcare Finland Oy, Helsinki, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191322 is the FDA 510(k) clearance record for E-EEGX, N-EEGX, a class II device, cleared for GE Healthcare Finland Oy on under FDA product code OLT (Non-Normalizing Quantitative Electroencephalograph Software). FDA's definition for product code OLT reads: "Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user". FDA records list 30 510(k) clearances for GE Healthcare Finland Oy, from to . As of , FDA records show no recalls naming K191322.

Clearance record

Decision date
Received
(252 days to decision)
Product code
OLT Non-Normalizing Quantitative Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
GE Healthcare Finland Oy Kuortaneenkatu 2, Helsinki, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLT

Trailing 12 months
4 clearances under product code OLT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20261
October 20260