Cleared Traditional

K933951 - VIDEO EEG OPTION MODIFICATION

K933951 is an FDA 510(k) clearance for VIDEO EEG OPTION MODIFICATION, manufactured by Esaote Biomedica Spa. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K933951 · Esaote Biomedica Spa · Neurology device
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Feb 1994
Decision
175d
Days
Class 2
Risk

K933951 is an FDA 510(k) clearance for the VIDEO EEG OPTION MODIFICATION. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Esaote Biomedica Spa (Indianapolis, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 175 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 Esaote Biomedica Spa devices

FDA 510(k) Submission Details - K933951

510(k) Number K933951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1993
Decision Date February 03, 1994
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
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 K933951.
CADWELL EASY WRITER AND EASY READER
K932407 · Cadwell Laboratories, Inc. · Mar 1994
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