GYE · Class II · 21 CFR 882.1855

FDA Product Code GYE: Encephalogram Telemetry System

Leading manufacturers include Telediagnostic Systems, Inc., Pharmaquest Corp. and Electro-Bio-Medical Services, Inc..

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 Jul 29, 1997
WIRELESS EEG RECORDING SYSTEM MODEL W32
K963195
Cme Telemetrix, Inc.
Neurology · 348d
Cleared May 16, 1997
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
K970659
Telediagnostic Systems, Inc.
Neurology · 84d
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 Mar 22, 1989
RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER
K885328
Telediagnostic Systems, Inc.
Neurology · 84d
Cleared Dec 05, 1988
ISO-100 ISOLATION AMPLIFIER
K883947
Telediagnostic Systems, Inc.
Neurology · 77d
Cleared Nov 30, 1988
DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES
K883461
Biohm, Inc.
Neurology · 110d
Cleared Dec 11, 1987
S-10 TELEPHONIC POLYSOMNOGRAPH
K874257
Telediagnostic Systems, Inc.
Neurology · 52d
Cleared May 01, 1987
M10 EEG MONITOR SCOPE
K871120
Telediagnostic Systems, Inc.
Neurology · 43d
Cleared Mar 27, 1986
MODAC-XXXX INTENSIVE MONITORING OF EEG
K860128
Grass-Telefactor Product Group
Neurology · 72d
Cleared Nov 29, 1983
TELEPHONE TRANSMITTER T-10 EEG
K833236
Pharmaquest Corp.
Radiology · 105d
Cleared Nov 29, 1983
TELEPHONIC RECEIVER R-10 EEG
K833880
Pharmaquest Corp.
Radiology · 13d
Cleared Aug 31, 1983
BRAEGEN III 10-CHANNEL TRANSMITTER-
K832304
Electro-Bio-Medical Services, Inc.
Neurology · 48d
Cleared Nov 16, 1981
EEG TELEPHONE TRANSMITTER, MODEL #T-7
K813010
Pharmaquest Corp.
Neurology · 20d
Cleared May 05, 1981
BRAEGEN EEG TRANSMITTER/RECEIVER SYS
K811093
Electro-Bio-Medical Services, Inc.
Neurology · 14d
Cleared Nov 26, 1980
MODEL T-6 EEG TELEPHONE TRANSMITTER
K802656
Telediagnostic Systems, Inc.
Neurology · 33d
Cleared Nov 12, 1980
MODEL AFR EEG TELEPHONE RECEIVER
K802657
Telediagnostic Systems, Inc.
Neurology · 19d
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