Cleared Traditional

K831324 - EEG 42/2P ELECTRO ENCEPHALOGRAPH

K831324 is an FDA 510(k) clearance for EEG 42/2P ELECTRO ENCEPHALOGRAPH, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K831324 · Nihon Kohden America, Inc. · Neurology device
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May 1983
Decision
32d
Days
Class 2
Risk

K831324 is an FDA 510(k) clearance for the EEG 42/2P ELECTRO ENCEPHALOGRAPH. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on May 27, 1983 after a review of 32 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K831324

510(k) Number K831324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date May 27, 1983
Days to Decision 32 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
116d faster than avg
Panel avg: 148d · This submission: 32d
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 96
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K831324.
ELECTROENCEPHALOGRAPH EEG
K850259 · Nicolet Biomedical Instruments · Apr 1985
DEL MAR AVIONICS 5509 NEURO-SCANNER
K841653 · Del Mar Avionics · Dec 1984
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K842714 · Nihon Kohden America, Inc. · Sep 1984
MEDILOG 9000 SYSTEM
K830295 · Oxford Medilog, Inc. · Mar 1983
ELECTROENCEPHALOGRAPH
K823140 · Nihon Kohden America, Inc. · Dec 1982
DEL MAR MODEL 5500 EEG SCANNER
K822700 · Del Mar Avionics · Oct 1982