Cleared Traditional

K831651 - EVOKED POTENTIAL SYSTEM 2000

K831651 is an FDA 510(k) clearance for EVOKED POTENTIAL SYSTEM 2000, manufactured by Ophthalmetric Corp.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K831651 · Ophthalmetric Corp. · Neurology device
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Sep 1983
Decision
112d
Days
Class 2
Risk

K831651 is an FDA 510(k) clearance for the EVOKED POTENTIAL SYSTEM 2000. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Ophthalmetric Corp. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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 Ophthalmetric Corp. devices

FDA 510(k) Submission Details - K831651

510(k) Number K831651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date September 12, 1983
Days to Decision 112 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 148d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 30
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K831651.
VPS 2250, CSU2250 & VFU 2250
K844659 · Madsen Electronics (Canada) , Ltd. · Feb 1985
SLS 3500 LED VISUAL STIMULATOR
K842381 · Nihon Kohden America, Inc. · Nov 1984
LED STIMULATOR LS-05
K834442 · Teca, Inc. · Aug 1984
BIOLOGIC SYSTEM BL 101
K831047 · Bio-Logic Systems Corp. · May 1983
STIMULATOR MODEL SSS-1101
K791149 · Nihon Kohden America, Inc. · Sep 1979
STIMULATOR, NIC-106 VISUAL
K790570 · Nicolet Biomedical Instruments · May 1979