Cleared Special

K063797 - GEODESIC EEG SYSTEM 300

K063797 is an FDA 510(k) clearance for GEODESIC EEG SYSTEM 300, manufactured by Electrical Geodesics, Incorporated. The device is a Class 2 Neurology device with product code OLT cleared through the Special 510(k) pathway after a 34-day FDA review.

K063797 · Electrical Geodesics, Incorporated · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
34d
Days
Class 2
Risk

K063797 is an FDA 510(k) clearance for the GEODESIC EEG SYSTEM 300. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Electrical Geodesics, Incorporated (Eugene, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063797

510(k) Number K063797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date January 25, 2007
Days to Decision 34 days
Submission Type Special
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
115d faster than avg
Panel avg: 149d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

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 53
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K063797.
ZOOM-100DC
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MODEL I-2000 MONITOR
K072382 · Infinite Biomedical Technologies · Feb 2008
BWII EEG DIGITAL, MODEL PV 1652
K062533 · Neurovirtual USA, Inc. · Dec 2006
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
K051883 · Ge Healthcare · Aug 2005
BRM2 BRAIN MONITOR
K033010 · Brainz Instruments , Ltd. · Oct 2003
K063797 · GEODESIC EEG SYSTEM 300
Download PDF FDA Summary Electrical Geodesics,…