Cleared Traditional

K982479 - EXCEL AMBULATORY EEG

K982479 is the FDA 510(k) clearance for EXCEL AMBULATORY EEG by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982479 · Excel Tech. , Ltd. · Neurology device
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Oct 1998
Decision
90d
Days
Class 2
Risk

K982479 is an FDA 510(k) clearance for the EXCEL AMBULATORY EEG. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on October 14, 1998 after a review of 90 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K982479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1998
Decision Date October 14, 1998
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 88
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K982479.
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
K000919 · Excel Tech. , Ltd. · Aug 2000
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
K001103 · Excel Tech. , Ltd. · Jun 2000
EEG WITH VIDEO, MODEL EX-NW
K000898 · Excel Tech. , Ltd. · Apr 2000
EXCEL NEURO WORKS
K980214 · Excel Tech. , Ltd. · Apr 1998
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM
K973883 · Bio-Logic Systems Corp. · Mar 1998
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K954954 · Bio-Logic Systems Corp. · Jan 1996