Cleared Traditional

K911229 - PHOENIX DIGITAL EEG SYSTEM

K911229 is an FDA 510(k) clearance for PHOENIX DIGITAL EEG SYSTEM, manufactured by Dantec Medical, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K911229 · Dantec Medical, Inc. · Neurology device
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Sep 1991
Decision
194d
Days
Class 2
Risk

K911229 is an FDA 510(k) clearance for the PHOENIX DIGITAL EEG SYSTEM. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on September 30, 1991 after a review of 194 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 Dantec Medical, Inc. devices

FDA 510(k) Submission Details - K911229

510(k) Number K911229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1991
Decision Date September 30, 1991
Days to Decision 194 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 148d · This submission: 194d
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 94
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K911229.
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
HORIZON 2000 EEG MONITORING OPTION
K910945 · Mennen Medical, Inc. · Aug 1991
MENTOR EEG SYSTEM
K904763 · Oxford Medilog, Inc. · Apr 1991
EEG-5400 SERIES
K902550 · Nihon Kohden America, Inc. · Mar 1991