Cleared Traditional

K844481 - NEUROLAB II (FDA 510(k) Clearance)

Class I Neurology device.

K844481 · Teca, Inc. · Neurology device
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May 1985
Decision
182d
Days
Class 1
Risk

K844481 is an FDA 510(k) clearance for the NEUROLAB II. Classified as Analyzer, Spectrum, Electroencephalogram Signal (product code GWS), Class I - General Controls.

Submitted by Teca, Inc. (Pleasantiville, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 182 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 Teca, Inc. devices

Submission Details

510(k) Number K844481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date May 20, 1985
Days to Decision 182 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 148d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.