GYEClass II

Encephalogram Telemetry System

21 CFR 882.1855 / Neurology

GYE is the FDA product code for Encephalogram Telemetry System, a class II device type, regulated under 21 CFR 882.1855. As of 2026-09-10, FDA records hold 20 510(k) clearances under this code, the most recent dated 1997-07-29, and no recalls.

Classification record

Product code: GYE
Device name: Encephalogram Telemetry System
Regulation: 21 CFR 882.1855
Device class: Class II
Review panel: Neurology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 20
Ingested recalls: 0

Clearances, product code GYE

By decision year

20 clearances under product code GYE with a decision year between 1976 and 1997, 1980 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code GYE by decision year
Year	Clearances
1976	1
1980	4
1981	2
1983	3
1986	1
1987	2
1988	2
1989	2
1990	1
1997	2

Applicants with the most clearances

Product code GYE

Applicants holding the most 510(k) clearances under product code GYE
Applicant	Clearances
Telediagnostic Systems, Inc.	7
Pharmaquest Corp.	3
Electro-Bio-Medical Services, Inc.	2
Biohm, Inc.	1
Buckman Co., Inc.	1
Burdick Corp.	1
Cme Telemetrix, Inc.	1
General Electric Co.	1
Grass-Telefactor Product Group	1
Mennen Medical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GYE.