Cleared Traditional

K974748 - NEUROMETRIC ANALYSIS SYSTEM

K974748 is an FDA 510(k) clearance for NEUROMETRIC ANALYSIS SYSTEM, manufactured by Nxlink, Ltd.. The device is a Class 2 Neurology device with product code OLU cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K974748 · Nxlink, Ltd. · Neurology device
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Jul 1998
Decision
203d
Days
Class 2
Risk

K974748 is an FDA 510(k) clearance for the NEUROMETRIC ANALYSIS SYSTEM. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by Nxlink, Ltd. (Richland, US). The FDA issued a Cleared decision on July 10, 1998 after a review of 203 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 Nxlink, Ltd. devices

FDA 510(k) Submission Details - K974748

510(k) Number K974748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date July 10, 1998
Days to Decision 203 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
55d slower than avg
Panel avg: 148d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLU Device Classification - Class 2, Special Controls

Product Code OLU Normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database 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.