Cleared Traditional

K904763 - MENTOR EEG SYSTEM

K904763 is an FDA 510(k) clearance for MENTOR EEG SYSTEM, manufactured by Oxford Medilog, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K904763 · Oxford Medilog, Inc. · Neurology device
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Apr 1991
Decision
170d
Days
Class 2
Risk

K904763 is an FDA 510(k) clearance for the MENTOR EEG SYSTEM. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 10, 1991 after a review of 170 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxford Medilog, Inc. devices

FDA 510(k) Submission Details - K904763

510(k) Number K904763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1990
Decision Date April 10, 1991
Days to Decision 170 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 148d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWQ Full-montage Standard Electroencephalograph

All 93
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K904763.
THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH
K923950 · Biosound, Inc. · Jan 1993
NEUROFAX EEG 5532
K915096 · Nihon Kohden America, Inc. · Mar 1992
HORIZON 2000 EEG MONITORING OPTION
K910945 · Mennen Medical, Inc. · Aug 1991
EEG-5400 SERIES
K902550 · Nihon Kohden America, Inc. · Mar 1991
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004 · Teca, Inc. · Nov 1990
SPACELABS MODEL 90480 EEG MODULE
K896942 · Spacelabs, Inc. · Mar 1990