Cleared Traditional

K883340 - NEURAL MAGNETIC STIMULATOR

K883340 is the FDA 510(k) clearance for NEURAL MAGNETIC STIMULATOR by Tracor Northern, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K883340 · Tracor Northern, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
142d
Days
Class 2
Risk

K883340 is an FDA 510(k) clearance for the NEURAL MAGNETIC STIMULATOR, THE D190. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Tracor Northern, Inc. (Middleton, US). The FDA issued a Cleared decision on December 29, 1988 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 K883340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date December 29, 1988
Days to Decision 142 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 faster than avg
Panel avg: 148d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 51
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K883340.
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · Nihon Kohden America, Inc. · Feb 1992
HIGH SPEED MAGNETIC STIMULATOR
K905059 · Cadwell Laboratories, Inc. · Sep 1991
MEM-7102
K890274 · Nihon Kohden America, Inc. · May 1989
CADWELL EXCEL
K880088 · Cadwell Laboratories, Inc. · May 1988
NOVAMETRIX MODEL 200 MAGSTIM
K871338 · Novametrix Medical Systems, Inc. · Aug 1987
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
K863175 · Cadwell Laboratories, Inc. · Jan 1987