Cleared Traditional

K860903 - TM-3600 A NEURODIAGNOSTIC SYSTEM

K860903 is the FDA 510(k) clearance for TM-3600 A NEURODIAGNOSTIC SYSTEM by Tracor Northern, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K860903 · Tracor Northern, Inc. · Neurology device
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Jun 1986
Decision
87d
Days
Class 2
Risk

K860903 is an FDA 510(k) clearance for the TM-3600 A NEURODIAGNOSTIC SYSTEM. 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 June 5, 1986 after a review of 87 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K860903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date June 05, 1986
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
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 K860903.
NOVAMETRIX MODEL 200 MAGSTIM
K871338 · Novametrix Medical Systems, Inc. · Aug 1987
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
K863175 · Cadwell Laboratories, Inc. · Jan 1987
TRAVELER LT
K862690 · Bio-Logic Systems Corp. · Nov 1986
NEUROPACK 8, MEE-4108
K851300 · Nihon Kohden America, Inc. · Jun 1985
BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
K844992 · Bio-Logic Systems Corp. · Jun 1985
QUANTUM 84
K844707 · Cadwell Laboratories, Inc. · May 1985