Cleared Special

K010091 - EEG WITH VIDEO

K010091 is the FDA 510(k) clearance for EEG WITH VIDEO by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code GWQ) cleared through the Special 510(k) pathway after a 21-day FDA review.

K010091 · Excel Tech. , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
21d
Days
Class 2
Risk

K010091 is an FDA 510(k) clearance for the EEG WITH VIDEO, MODEL EX-NW. 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 February 1, 2001 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Excel Tech. , Ltd. devices

Submission Details

510(k) Number K010091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date February 01, 2001
Days to Decision 21 days
Submission Type Special
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
127d faster than avg
Panel avg: 148d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K010091.
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K010089 · Excel Tech. , Ltd. · Mar 2001
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
K010084 · Excel Tech. , Ltd. · Mar 2001
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150 · Excel Tech. , Ltd. · Feb 2001
BIO-LOGIC CEEGRAPH NETLINK
K002570 · Bio-Logic Systems Corp. · Sep 2000
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