GYE · Class II · 21 CFR 882.1855

FDA Product Code GYE: Encephalogram Telemetry System

Leading manufacturers include General Electric Co., Burdick Corp. and Physio-Control Corp..

20
Total
20
Cleared
76d
Avg days
1976
Since

FDA 510(k) Cleared Encephalogram Telemetry System Devices (Product Code GYE)

20 devices
1–20 of 20
Cleared Feb 22, 1990
MODEL 219 TELEMETRY SYSTEM
K895895
Mennen Medical, Inc.
Neurology · 139d
Cleared Aug 02, 1989
BMS-2000 MOBILE EEG SYSTEM
K891405
Buckman Co., Inc.
Neurology · 141d
Cleared Jan 31, 1980
TELEMETRY SYSTEM XMT-1 & REC-1
K792371
Burdick Corp.
Neurology · 66d
Cleared Jan 04, 1980
CMS 6000
K792380
Physio-Control Corp.
Neurology · 39d
Cleared Dec 21, 1976
G.E. TELEMETRY MONITORING
K761259
General Electric Co.
Neurology · 6d

About Product Code GYE - Regulatory Context