Cleared Traditional

K884537 - AE-800PA EEG MODULE

K884537 is an FDA 510(k) clearance for AE-800PA EEG MODULE, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K884537 · Nihon Kohden America, Inc. · Neurology device
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Dec 1988
Decision
62d
Days
Class 2
Risk

K884537 is an FDA 510(k) clearance for the AE-800PA EEG MODULE. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on December 29, 1988 after a review of 62 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K884537

510(k) Number K884537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1988
Decision Date December 29, 1988
Days to Decision 62 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
86d faster than avg
Panel avg: 148d · This submission: 62d
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 K884537.
CEEGRAPH
K895125 · Bio-Logic Systems Corp. · Dec 1989
CADWELL FREEDOM EEG DEVICE
K894276 · Cadwell Laboratories, Inc. · Sep 1989
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
K890881 · Teca, Inc. · Mar 1989
KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265
K870815 · Kontron Instruments, Inc. · Feb 1988
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K874796 · Nihon Kohden America, Inc. · Jan 1988
NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM
K873535 · Nicolet Biomedical Instruments · Oct 1987