510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012466Substantially Equivalent

Bis/eeg Module

General Electric Medical Systems Information Techn, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012466 is the FDA 510(k) clearance record for BIS/EEG MODULE, a class II device, cleared for General Electric Medical Systems Information Techn on under FDA product code OLW (Index-Generating Electroencephalograph Software). FDA's definition for product code OLW reads: "Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user". FDA records list 33 510(k) clearances for General Electric Medical Systems Information Techn, from to . As of , FDA records show no recalls naming K012466.

Clearance record

Decision date
Received
(61 days to decision)
Product code
OLW Index-Generating Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
General Electric Medical Systems Information Techn 8200 W. Tower Ave., Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code OLW

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