Cleared Traditional

K802657 - MODEL AFR EEG TELEPHONE RECEIVER

K802657 is the FDA 510(k) clearance for MODEL AFR EEG TELEPHONE RECEIVER by Telediagnostic Systems, Inc.. It is a Class 2 Neurology device (product code GYE) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K802657 · Telediagnostic Systems, Inc. · Neurology device
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Nov 1980
Decision
19d
Days
Class 2
Risk

K802657 is an FDA 510(k) clearance for the MODEL AFR EEG TELEPHONE RECEIVER. Classified as Encephalogram Telemetry System (product code GYE), Class II - Special Controls.

Submitted by Telediagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 19 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.

View all Telediagnostic Systems, Inc. devices

Submission Details

510(k) Number K802657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1980
Decision Date November 12, 1980
Days to Decision 19 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 148d · This submission: 19d
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.