Cleared Traditional

K923043 - SPECTRAL EEG MONITOR MODEL A1000

K923043 is an FDA 510(k) clearance for SPECTRAL EEG MONITOR MODEL A1000, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 162-day FDA review.

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

FDA 510(k) Submission Details - K923043

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
Combination Product No
PCCP Authorized No
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.

OLT Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K923043.
SIEMENS INFINITY EEG POD
K991012 · Siemens Medical Solutions USA, Inc. · Jun 1999
A-1050 EEG MONITOR
K952347 · Aspect Medical Systems, Inc. · Jan 1996
TOPOGRAPHIC BRAIN MAPPING OPTION
K934050 · Biosound, Inc. · Feb 1994
TECA NEUROMAPPER 386
K894889 · Teca, Inc. · Dec 1989
TECA NEUROMAPPER 1620, BRAIN MAPPER
K894088 · Teca, Inc. · Nov 1989
SLEEP STAGER
K850541 · Oxford Medilog, Inc. · Aug 1985