Cleared Traditional

K843815 - EVOMATIC 8000/4000

K843815 is the FDA 510(k) clearance for EVOMATIC 8000/4000 by Dantec Electronics, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K843815 · Dantec Electronics, Inc. · Neurology device
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May 1985
Decision
245d
Days
Class 2
Risk

K843815 is an FDA 510(k) clearance for the EVOMATIC 8000/4000. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Dantec Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on May 31, 1985 after a review of 245 days - an extended review 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: 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 Dantec Electronics, Inc. devices

Submission Details

510(k) Number K843815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date May 31, 1985
Days to Decision 245 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 148d · This submission: 245d
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 K843815.
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
EVOKED POTENTIAL SYS
K842543 · Bio-Logic Systems Corp. · Nov 1984
CADWELL 8400
K830771 · Cadwell Laboratories, Inc. · Apr 1983