Cleared Traditional

K082614 - EVOX ELECTRO DIAGNOSTIC DEVICE

K082614 is an FDA 510(k) clearance for EVOX ELECTRO DIAGNOSTIC DEVICE, manufactured by Laborie Medical Technologies, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K082614 · Laborie Medical Technologies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
178d
Days
Class 2
Risk

K082614 is an FDA 510(k) clearance for the EVOX ELECTRO DIAGNOSTIC DEVICE. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Laborie Medical Technologies, Inc. (Williston, US). The FDA issued a Cleared decision on March 6, 2009 after a review of 178 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.

FDA 510(k) Submission Details - K082614

510(k) Number K082614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2008
Decision Date March 06, 2009
Days to Decision 178 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 149d · This submission: 178d
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 123
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K082614.
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K071969 · Nihon Kohden America, Inc. · Oct 2008
K082614 · EVOX ELECTRO DIAGNOSTIC DEVICE
Download PDF FDA Summary Laborie Medical Techn…