GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

Leading manufacturers include Empi, Medtronic Vascular and Aspect Medical Systems, Inc..

441
Total
441
Cleared
127d
Avg days
1976
Since
441 devices
241–264 of 441
Cleared May 09, 1997
VALUETRODE
K970426
Axelgaard Mfg. Co., Ltd.
Neurology · 94d
Cleared Mar 06, 1997
MEDICOM, TENS ELECTRODES
K965194
Medicotest A/S
Neurology · 72d
Cleared Jan 27, 1997
AQUABOND ELECTRODE
K964433
Medibond , Ltd.
Neurology · 83d
Cleared Dec 16, 1996
EEG ELECTRODES
K962283
Teca, Inc.
Neurology · 186d
Cleared Nov 15, 1996
M & R DISPOSABLE ELECTRODE (14200)
K963236
M & R Mfg., Inc.
Neurology · 88d
Cleared Oct 04, 1996
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961821
Aspect Medical Systems, Inc.
Neurology · 147d
Cleared May 10, 1996
EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
K961141
Uni-Patch, Inc.
Neurology · 50d
Cleared May 10, 1996
MODEL 1220, OR E-NET (54-62 CM)
K961609
Physiometrix, Inc.
Neurology · 15d
Cleared Apr 26, 1996
MODEL 1210, MEDIUM E-NET
K960873
Physiometrix, Inc.
Neurology · 53d
Cleared Apr 26, 1996
MODEL 1240, SMALL E NET
K960885
Physiometrix, Inc.
Neurology · 53d
Cleared Apr 15, 1996
HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500
K960732
Physiometrix, Inc.
Neurology · 53d
Cleared Jan 22, 1996
EMG DISC RECORDING ELECTRODE
K953354
Chalgren Enterprises, Inc.
Neurology · 189d
Cleared Jan 22, 1996
EMG RECORDING RING ELECTRODE
K953356
Chalgren Enterprises, Inc.
Neurology · 189d
Cleared Jan 22, 1996
EMG DISC RECORDING ELECTRODE
K953361
Chalgren Enterprises, Inc.
Neurology · 189d
Cleared Jan 03, 1996
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K944314
Bio-Logic Systems Corp.
Neurology · 492d
Cleared Dec 06, 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952690
Chalgren Enterprises, Inc.
Neurology · 177d
Cleared Dec 06, 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952908
Chalgren Enterprises, Inc.
Neurology · 166d
Cleared Nov 15, 1995
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449
Henley Intl.
Neurology · 485d
Cleared Oct 06, 1995
22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN
K953219
Chalgren Enterprises, Inc.
Neurology · 88d
Cleared Oct 06, 1995
32MM NICKEL PLATED DISC ELECTRODE
K953220
Chalgren Enterprises, Inc.
Neurology · 88d
Cleared Sep 25, 1995
DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K
K952176
Medicotest, Inc.
Neurology · 140d
Cleared Jul 19, 1995
BIOFLEX GARMENTS, ASSORTED MODELS
K944543
Bioflex, Inc.
Neurology · 307d
Cleared Jun 22, 1995
MEDI-TRAC EEG ELECTRODE
K950782
Graphic Controls Corp.
Neurology · 121d
Cleared Apr 24, 1995
MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
K946318
Physiometrix, Inc.
Neurology · 117d