Cleared Traditional

K854662 - OEE_7102 EEG/TREND MONITOR

K854662 is an FDA 510(k) clearance for OEE_7102 EEG/TREND MONITOR, manufactured by Nihon Kohden America, Inc.. The device is a Class 1 Neurology device with product code GWS cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K854662 · Nihon Kohden America, Inc. · Neurology device
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Aug 1986
Decision
273d
Days
Class 1
Risk

K854662 is an FDA 510(k) clearance for the OEE_7102 EEG/TREND MONITOR. Classified as Analyzer, Spectrum, Electroencephalogram Signal (product code GWS), Class I - General Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on August 20, 1986 after a review of 273 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1420 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K854662

510(k) Number K854662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date August 20, 1986
Days to Decision 273 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
125d slower than avg
Panel avg: 148d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

GWS Device Classification - Class 1, General Controls

Product Code GWS Analyzer, Spectrum, Electroencephalogram Signal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GWS Analyzer, Spectrum, Electroencephalogram Signal

Devices cleared under the same product code (GWS) and FDA review panel - the closest regulatory comparables to K854662.
NEUROLAB II
K844481 · Teca, Inc. · May 1985