Cleared Traditional

K903734 - ADVANTAGE EP

K903734 is an FDA 510(k) clearance for ADVANTAGE EP, manufactured by Clark Davis Medical Systems, Inc.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K903734 · Clark Davis Medical Systems, Inc. · Neurology device
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Jul 1991
Decision
340d
Days
Class 2
Risk

K903734 is an FDA 510(k) clearance for the ADVANTAGE EP. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Clark Davis Medical Systems, Inc. (London, Ontario, CA). The FDA issued a Cleared decision on July 22, 1991 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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. Elevated predicate reliance profile. 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 Clark Davis Medical Systems, Inc. devices

FDA 510(k) Submission Details - K903734

510(k) Number K903734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date July 22, 1991
Days to Decision 340 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 148d · This submission: 340d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 30
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