Cleared Traditional

SPECTRAL EEG MONITOR MODEL A1000 (K923043) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923043 · Aspect Medical Systems, Inc. · Neurology device
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Dec 1992
Decision
162d
Days
Class 2
Risk

K923043 is an FDA 510(k) clearance for the SPECTRAL EEG MONITOR MODEL A1000. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Framingham, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 162 days - an extended review 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: 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 Aspect Medical Systems, Inc. devices

Submission Details

510(k) Number K923043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1992
Decision Date December 03, 1992
Days to Decision 162 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 148d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 53
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K923043.
HippoMind (v1.0)
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VEEGix EEG System
K240593 · Neuroservo, Inc. · Aug 2024
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254 · Neurosoft , Ltd. · Nov 2022
Wireless EEG System
K213299 · Pascall Systems, Inc. · May 2022
E-EEGX, N-EEGX
K191322 · GE Healthcare Finland Oy · Jan 2020