Cleared Traditional

K970659 - DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER

K970659 is an FDA 510(k) clearance for DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 ..., manufactured by Telediagnostic Systems, Inc.. The device is a Class 2 Neurology device with product code GYE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K970659 · Telediagnostic Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
84d
Days
Class 2
Risk

K970659 is an FDA 510(k) clearance for the DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER. Classified as Encephalogram Telemetry System (product code GYE), Class II - Special Controls.

Submitted by Telediagnostic Systems, Inc. (San Francisco, US). The FDA issued a Cleared decision on May 16, 1997 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K970659

510(k) Number K970659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1997
Decision Date May 16, 1997
Days to Decision 84 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
65d faster than avg
Panel avg: 149d · This submission: 84d
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 8
Devices cleared under the same product code (GYE) and FDA review panel - the closest regulatory comparables to K970659.
WIRELESS EEG RECORDING SYSTEM MODEL W32
K963195 · Cme Telemetrix, Inc. · Jul 1997
MODEL 219 TELEMETRY SYSTEM
K895895 · Mennen Medical, Inc. · Feb 1990
BMS-2000 MOBILE EEG SYSTEM
K891405 · Buckman Co., Inc. · Aug 1989
M10 EEG MONITOR SCOPE
K871120 · Telediagnostic Systems, Inc. · May 1987
MODAC-XXXX INTENSIVE MONITORING OF EEG
K860128 · Grass-Telefactor Product Group · Mar 1986
TELEMETRY SYSTEM XMT-1 & REC-1
K792371 · Burdick Corp. · Jan 1980
K970659 · DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
Download PDF Telediagnostic System…