Cleared Traditional

K842964 - PHOTIC STIMULATOR TM-3030-70

K842964 is the FDA 510(k) clearance for PHOTIC STIMULATOR TM-3030-70 by Tracor Northern, Inc.. It is a Class 2 Neurology device (product code GWE) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K842964 · Tracor Northern, Inc. · Neurology device
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Dec 1984
Decision
154d
Days
Class 2
Risk

K842964 is an FDA 510(k) clearance for the PHOTIC STIMULATOR TM-3030-70. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Tracor Northern, Inc. (Middleton, US). The FDA issued a Cleared decision on December 28, 1984 after a review of 154 days - an extended review 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: 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 Tracor Northern, Inc. devices

Submission Details

510(k) Number K842964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1984
Decision Date December 28, 1984
Days to Decision 154 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 148d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K842964.
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K860801 · Cadwell Laboratories, Inc. · Nov 1986
MODIFIED BRAIN ATLAS III
K854362 · Bio-Logic Systems Corp. · Apr 1986
L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533 · Bio-Logic Systems Corp. · Dec 1985
SLS 3500 LED VISUAL STIMULATOR
K842381 · Nihon Kohden America, Inc. · Nov 1984
BIOLOGIC SYSTEM BL 101
K831047 · Bio-Logic Systems Corp. · May 1983
STIMULATOR MODEL SSS-1101
K791149 · Nihon Kohden America, Inc. · Sep 1979