Cleared Traditional

K923894 - YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH

K923894 is an FDA 510(k) clearance for YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH, manufactured by Biosound, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K923894 · Biosound, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
218d
Days
Class 2
Risk

K923894 is an FDA 510(k) clearance for the YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 10, 1993 after a review of 218 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 Biosound, Inc. devices

FDA 510(k) Submission Details - K923894

510(k) Number K923894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date March 10, 1993
Days to Decision 218 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 148d · This submission: 218d
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 93
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K923894.
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
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