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
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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

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
200d slower than avg
Panel avg: 148d · 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

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
TELEMETRY SYSTEM XMT-1 & REC-1
K792371 · Burdick Corp. · Jan 1980
CMS 6000
K792380 · Physio-Control Corp. · Jan 1980
G.E. TELEMETRY MONITORING
K761259 · General Electric Co. · Dec 1976