Cleared Traditional

K000919 - 128 CHANNEL EEG HEADBOX

K000919 is the FDA 510(k) clearance for 128 CHANNEL EEG HEADBOX by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K000919 · Excel Tech. , Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
162d
Days
Class 2
Risk

K000919 is an FDA 510(k) clearance for the 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on August 31, 2000 after a review of 162 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K000919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2000
Decision Date August 31, 2000
Days to Decision 162 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 148d · This submission: 162d
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 K000919.
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150 · Excel Tech. , Ltd. · Feb 2001
EEG WITH VIDEO, MODEL EX-NW
K010091 · Excel Tech. , Ltd. · Feb 2001
BIO-LOGIC CEEGRAPH NETLINK
K002570 · Bio-Logic Systems Corp. · Sep 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 AMBULATORY EEG
K982479 · Excel Tech. , Ltd. · Oct 1998