Cleared Traditional

K896942 - SPACELABS MODEL 90480 EEG MODULE

K896942 is an FDA 510(k) clearance for SPACELABS MODEL 90480 EEG MODULE, manufactured by Spacelabs, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K896942 · Spacelabs, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
85d
Days
Class 2
Risk

K896942 is an FDA 510(k) clearance for the SPACELABS MODEL 90480 EEG MODULE. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on March 8, 1990 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spacelabs, Inc. devices

FDA 510(k) Submission Details - K896942

510(k) Number K896942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date March 08, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 148d · This submission: 85d
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 K896942.
MENTOR EEG SYSTEM
K904763 · Oxford Medilog, Inc. · Apr 1991
EEG-5400 SERIES
K902550 · Nihon Kohden America, Inc. · Mar 1991
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004 · Teca, Inc. · Nov 1990
P460, DG32 ELECTROENCEPHALOGRAPH
K896666 · Teca, Inc. · Feb 1990
CEEGRAPH
K895125 · Bio-Logic Systems Corp. · Dec 1989
CADWELL FREEDOM EEG DEVICE
K894276 · Cadwell Laboratories, Inc. · Sep 1989