Cleared Traditional

K843253 - EMG/NCV & EVOKED RESPONSE, DESIGN W/

K843253 is an FDA 510(k) clearance for EMG/NCV & EVOKED RESPONSE, manufactured by Neurodiagnostics, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K843253 · Neurodiagnostics, Inc. · Neurology device
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Nov 1984
Decision
92d
Days
Class 2
Risk

K843253 is an FDA 510(k) clearance for the EMG/NCV & EVOKED RESPONSE, DESIGN W/. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Neurodiagnostics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 92 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 Neurodiagnostics, Inc. devices

FDA 510(k) Submission Details - K843253

510(k) Number K843253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date November 20, 1984
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 148d · This submission: 92d
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 K843253.
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
CADWELL 8400
K830771 · Cadwell Laboratories, Inc. · Apr 1983
#ST10 PROGR. EVOKED RESPONSE STIMULATOR
K822744 · Teca, Inc. · Nov 1982