Cleared Traditional

K894629 - NICOLET BEAM II SYSTEM

K894629 is an FDA 510(k) clearance for NICOLET BEAM II SYSTEM, manufactured by Nicolet Instrument Corp.. The device is a Class 1 Neurology device with product code GWS cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K894629 · Nicolet Instrument Corp. · Neurology device
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Mar 1990
Decision
228d
Days
Class 1
Risk

K894629 is an FDA 510(k) clearance for the NICOLET BEAM II SYSTEM. Classified as Analyzer, Spectrum, Electroencephalogram Signal (product code GWS), Class I - General Controls.

Submitted by Nicolet Instrument Corp. (Madison, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 228 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 Nicolet Instrument Corp. devices

FDA 510(k) Submission Details - K894629

510(k) Number K894629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date March 09, 1990
Days to Decision 228 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 148d · This submission: 228d
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.