Cleared Special

EPI-SCAN, MODEL P 100 (K032935) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032935 · Edx Epi-Scan, Inc. · Neurology device
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Nov 2003
Decision
59d
Days
Class 2
Risk

K032935 is an FDA 510(k) clearance for the EPI-SCAN, MODEL P 100. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Edx Epi-Scan, Inc. (Irvine, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1540 - 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.

View all Edx Epi-Scan, Inc. devices

Submission Details

510(k) Number K032935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date November 20, 2003
Days to Decision 59 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 148d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GZO Device, Galvanic Skin Response Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1540
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.