Cleared Traditional

K963195 - WIRELESS EEG RECORDING SYSTEM MODEL W32

K963195 is an FDA 510(k) clearance for WIRELESS EEG RECORDING SYSTEM MODEL W32, manufactured by Cme Telemetrix, Inc.. The device is a Class 2 Neurology device with product code GYE cleared through the Traditional 510(k) pathway after a 348-day FDA review.

K963195 · Cme Telemetrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K963195

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 149d · This submission: 348d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYE Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GYE Encephalogram Telemetry System

All 19
Devices cleared under the same product code (GYE) and FDA review panel - the closest regulatory comparables to K963195.
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
K970659 · Telediagnostic Systems, Inc. · May 1997
MODEL 219 TELEMETRY SYSTEM
K895895 · Mennen Medical, Inc. · Feb 1990
BMS-2000 MOBILE EEG SYSTEM
K891405 · Buckman Co., Inc. · Aug 1989
RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER
K885328 · Telediagnostic Systems, Inc. · Mar 1989
ISO-100 ISOLATION AMPLIFIER
K883947 · Telediagnostic Systems, Inc. · Dec 1988
DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES
K883461 · Biohm, Inc. · Nov 1988
K963195 · WIRELESS EEG RECORDING SYSTEM MODEL W32
Download PDF Cme Telemetrix, Inc.