Cleared Traditional

K832084 - EVOKED 3500 POTENTIAL SYSTEM

K832084 is an FDA 510(k) clearance for EVOKED 3500 POTENTIAL SYSTEM, manufactured by Tracor Northern, Inc.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K832084 · Tracor Northern, Inc. · Neurology device
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Aug 1983
Decision
49d
Days
Class 2
Risk

K832084 is an FDA 510(k) clearance for the EVOKED 3500 POTENTIAL SYSTEM. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Tracor Northern, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tracor Northern, Inc. devices

FDA 510(k) Submission Details - K832084

510(k) Number K832084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date August 16, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 148d · This submission: 49d
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 K832084.
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