Cleared Traditional

K842964 - PHOTIC STIMULATOR TM-3030-70

K842964 is an FDA 510(k) clearance for PHOTIC STIMULATOR TM-3030-70, 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 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

FDA 510(k) Submission Details - K842964

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.

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 K842964.
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