Cleared Traditional

K973883 - BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDIN...

K973883 is an FDA 510(k) clearance for BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDIN..., manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K973883 · Bio-Logic Systems Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
142d
Days
Class 2
Risk

K973883 is an FDA 510(k) clearance for the BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on March 5, 1998 after a review of 142 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 Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K973883

510(k) Number K973883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date March 05, 1998
Days to Decision 142 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
6d faster than avg
Panel avg: 148d · This submission: 142d
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 96
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K973883.
EEG WITH VIDEO, MODEL EX-NW
K000898 · Excel Tech. , Ltd. · Apr 2000
EXCEL AMBULATORY EEG
K982479 · Excel Tech. , Ltd. · Oct 1998
EXCEL NEURO WORKS
K980214 · Excel Tech. , Ltd. · Apr 1998
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K954954 · Bio-Logic Systems Corp. · Jan 1996
CADWELL EASY AMBULATORY EEG
K946094 · Cadwell Laboratories, Inc. · Sep 1995
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678 · Nihon Kohden America, Inc. · May 1995