Cleared Traditional

K924179 - EEG MODEL 24/32

K924179 is an FDA 510(k) clearance for EEG MODEL 24/32, manufactured by Lama Engineering, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K924179 · Lama Engineering, Inc. · Neurology device
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Jun 1993
Decision
307d
Days
Class 2
Risk

K924179 is an FDA 510(k) clearance for the EEG MODEL 24/32. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Lama Engineering, Inc. (Temple City, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Lama Engineering, Inc. devices

FDA 510(k) Submission Details - K924179

510(k) Number K924179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1992
Decision Date June 22, 1993
Days to Decision 307 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 148d · This submission: 307d
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 K924179.
CEEGRAPH, MODIFICATION
K933233 · Bio-Logic Systems Corp. · Mar 1994
SPACELABS MEDICAL MODEL 90481 EEG MODULE
K932842 · Spacelabs Medical, Inc. · Mar 1994
E*NET NEUROMONITORING SYSTEM
K930080 · Physiometrix, Inc. · Oct 1993
YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
K923894 · Biosound, Inc. · Mar 1993
THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR
K923860 · Biosound, Inc. · Feb 1993
THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH
K923950 · Biosound, Inc. · Jan 1993