Cleared Special

K081151 - COMPUMEDICS NEUVO

K081151 is an FDA 510(k) clearance for COMPUMEDICS NEUVO, manufactured by Compumedics USA, Ltd.. The device is a Class 2 Neurology device with product code GWQ cleared through the Special 510(k) pathway after a 138-day FDA review.

K081151 · Compumedics USA, Ltd. · Neurology device
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Sep 2008
Decision
138d
Days
Class 2
Risk

K081151 is an FDA 510(k) clearance for the COMPUMEDICS NEUVO. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Compumedics USA, Ltd. (Charlotte, US). The FDA issued a Cleared decision on September 8, 2008 after a review of 138 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Compumedics USA, Ltd. devices

FDA 510(k) Submission Details - K081151

510(k) Number K081151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2008
Decision Date September 08, 2008
Days to Decision 138 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 148d · This submission: 138d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 113
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