Cleared Traditional

WIRELESS EEG RECORDING SYSTEM MODEL W32 (K963195) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963195 · Cme Telemetrix, Inc. · Neurology device
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Jul 1997
Decision
348d
Days
Class 2
Risk

K963195 is an FDA 510(k) clearance for the WIRELESS EEG RECORDING SYSTEM MODEL W32. Classified as Encephalogram Telemetry System (product code GYE), Class II - Special Controls.

Submitted by Cme Telemetrix, Inc. (West Cadwell, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1855 - 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 Cme Telemetrix, Inc. devices

Submission Details

510(k) Number K963195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1996
Decision Date July 29, 1997
Days to Decision 348 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 148d · This submission: 348d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYE Encephalogram Telemetry System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1855
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.