Cleared Traditional

K952347 - A-1050 EEG MONITOR

K952347 is an FDA 510(k) clearance for A-1050 EEG MONITOR, 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 242-day FDA review.

K952347 · Aspect Medical Systems, Inc. · Neurology device
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Jan 1996
Decision
242d
Days
Class 2
Risk

K952347 is an FDA 510(k) clearance for the A-1050 EEG MONITOR. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Natick, US). The FDA issued a Cleared decision on January 16, 1996 after a review of 242 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 - K952347

510(k) Number K952347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1995
Decision Date January 16, 1996
Days to Decision 242 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 148d · This submission: 242d
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 K952347.
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
K051883 · Ge Healthcare · Aug 2005
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
K000892 · Datex-Ohmeda, Inc. · Jun 2000
SIEMENS INFINITY EEG POD
K991012 · Siemens Medical Solutions USA, Inc. · Jun 1999
TOPOGRAPHIC BRAIN MAPPING OPTION
K934050 · Biosound, Inc. · Feb 1994
SPECTRAL EEG MONITOR MODEL A1000
K923043 · Aspect Medical Systems, Inc. · Dec 1992
TECA NEUROMAPPER 386
K894889 · Teca, Inc. · Dec 1989