Cleared Traditional

K951507 - PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE

K951507 is an FDA 510(k) clearance for PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE, manufactured by Neuroconcepts, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K951507 · Neuroconcepts, Inc. · Neurology device
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Jul 1995
Decision
102d
Days
Class 2
Risk

K951507 is an FDA 510(k) clearance for the PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Neuroconcepts, Inc. (Middleton, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 102 days - within the typical 510(k) review window.

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 Neuroconcepts, Inc. devices

FDA 510(k) Submission Details - K951507

510(k) Number K951507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date July 14, 1995
Days to Decision 102 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 148d · This submission: 102d
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 143
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K951507.
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K954954 · Bio-Logic Systems Corp. · Jan 1996
MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
K953449 · Physiometrix, Inc. · Oct 1995
CADWELL EASY AMBULATORY EEG
K946094 · Cadwell Laboratories, Inc. · Sep 1995
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678 · Nihon Kohden America, Inc. · May 1995
CADWELL EASY WRITER AND EASY READER
K932407 · Cadwell Laboratories, Inc. · Mar 1994
CEEGRAPH, MODIFICATION
K933233 · Bio-Logic Systems Corp. · Mar 1994