Cleared Traditional

K980214 - EXCEL NEURO WORKS

K980214 is an FDA 510(k) clearance for EXCEL NEURO WORKS, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980214 · Excel Tech. , Ltd. · Neurology device
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Apr 1998
Decision
90d
Days
Class 2
Risk

K980214 is an FDA 510(k) clearance for the EXCEL NEURO WORKS. 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 April 21, 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

FDA 510(k) Submission Details - K980214

510(k) Number K980214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1998
Decision Date April 21, 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.

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 137
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K980214.
ACTIWATCH-SCORE
K991033 · Mini-Mitter Co., Inc. · Jun 1999
ACTIWATCH
K983533 · Mini-Mitter Co., Inc. · Mar 1999
EXCEL AMBULATORY EEG
K982479 · Excel Tech. , Ltd. · Oct 1998
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM
K973883 · Bio-Logic Systems Corp. · Mar 1998
NEUROAMP EEG AMPLIFIER
K974495 · Neurocorp, Ltd. · Feb 1998
CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
K971329 · Ctf Systems, Inc. · Nov 1997