GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

Leading manufacturers include Empi, Medtronic Vascular and Labeltape Meditect, Inc..

440
Total
440
Cleared
127d
Avg days
1976
Since
440 devices
169–192 of 440
Cleared Sep 14, 2000
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K002734
Aspect Medical Systems, Inc.
Neurology · 13d
Cleared May 11, 2000
MODEL 4300 PSARRAY EEG ELECTRODE SET
K001055
Physiometrix, Inc.
Neurology · 38d
Cleared Jan 18, 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330
Aspect Medical Systems, Inc.
Neurology · 26d
Cleared Dec 17, 1999
ULTRA-GARMENT ELECTRODE
K993130
Newwave Medical, LLC
Neurology · 88d
Cleared Sep 17, 1999
TENS/FES/NMES ELECTRODES
K983097
Uni-Patch, Inc.
Neurology · 389d
Cleared Aug 18, 1999
CUTANEOUS (BAR) ELECTRODE
K991769
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
CUTANEOUS (GROUND) ELECTRODE
K991770
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
DIGITAL RING ELECTRDE
K991771
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
CUTANEOUS (DISC) ELECTRODE
K991772
Neuro Supplies, Inc.
Neurology · 86d
Cleared Jun 22, 1999
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
K991199
Biomed Products
Neurology · 75d
Cleared Jun 18, 1999
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
K982096
Rapid Mfg. Co.
Neurology · 368d
Cleared Apr 20, 1999
EEG ELECTRODES MODEL 445 SERIES
K982053
Class A Ent.
Neurology · 313d
Cleared Apr 12, 1999
MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
K990370
Msb,Uk
Neurology · 63d
Cleared Dec 18, 1998
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
K983741
Axelgaard Mfg. Co., Ltd.
Neurology · 57d
Cleared Oct 22, 1998
SLE ELECTRODES AND ACCESSORIES
K980410
Specialized Laboratory Equipment, Ltd.
Neurology · 261d
Cleared Mar 26, 1998
TECA NCS ELECTRODE SYSTEM 2000
K971914
Medelec, Inc. D.B.A. Teca Corp.
Neurology · 307d
Cleared Feb 27, 1998
MSB TENS ELECTRODES (DISPOSABLE)
K980229
Msb , Ltd.
Neurology · 36d
Cleared Aug 29, 1997
DREAM CATCHER
K972122
Rest Technologies, Inc.
Neurology · 85d
Cleared May 15, 1997
NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K
K970639
Medicotest, Inc.
Neurology · 84d
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