Cleared Traditional

K843815 - EVOMATIC 8000/4000

K843815 is an FDA 510(k) clearance for EVOMATIC 8000/4000, manufactured by Dantec Electronics, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K843815

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.

GWF Device Classification - Class 2, Special Controls

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 104
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
COMPACT FOUR
K831896 · Nicolet Biomedical Instruments · Jul 1983