Cleared Traditional

K910945 - HORIZON 2000 EEG MONITORING OPTION

K910945 is the FDA 510(k) clearance for HORIZON 2000 EEG MONITORING OPTION by Mennen Medical, Inc.. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K910945 · Mennen Medical, Inc. · Neurology device
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Aug 1991
Decision
162d
Days
Class 2
Risk

K910945 is an FDA 510(k) clearance for the HORIZON 2000 EEG MONITORING OPTION. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on August 15, 1991 after a review of 162 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 Mennen Medical, Inc. devices

Submission Details

510(k) Number K910945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date August 15, 1991
Days to Decision 162 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
14d slower than avg
Panel avg: 148d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K910945.
THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR
K923860 · Biosound, Inc. · Feb 1993
THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH
K923950 · Biosound, Inc. · Jan 1993
NEUROFAX EEG 5532
K915096 · Nihon Kohden America, Inc. · Mar 1992
MENTOR EEG SYSTEM
K904763 · Oxford Medilog, Inc. · Apr 1991
EEG-5400 SERIES
K902550 · Nihon Kohden America, Inc. · Mar 1991
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004 · Teca, Inc. · Nov 1990