GWK · Class II · 21 CFR 882.1845

FDA Product Code GWK: Conditioner, Signal, Physiological

Leading manufacturers include Respironics, Inc., Nicolet Biomedical Instruments and Bio-Logic Systems Corp..

23
Total
23
Cleared
88d
Avg days
1977
Since

FDA 510(k) Cleared Conditioner, Signal, Physiological Devices (Product Code GWK)

23 devices
1–23 of 23
Cleared Sep 22, 2006
ACTICAL
K060919
Respironics, Inc.
Neurology · 171d
Cleared Aug 31, 2006
VITALSENSE XHR
K061870
Respironics, Inc.
Neurology · 59d
Cleared Sep 27, 2005
ACTIHEART
K052489
Respironics, Inc.
Neurology · 15d
Cleared Sep 21, 1999
MINI-LOGGER SERIES 2000
K991045
Mini-Mitter Co., Inc.
Neurology · 176d
Cleared Jun 28, 1991
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
K905594
Nihon Kohden America, Inc.
Neurology · 197d
Cleared Oct 06, 1987
BIO-LOGIC BANKER
K872290
Bio-Logic Systems Corp.
Neurology · 112d
Cleared Apr 11, 1985
BRAIN FUNCTION MAPPING OPTION FOR PATHF
K843598
Nicolet Biomedical Instruments
Neurology · 211d
Cleared Jun 07, 1984
NEUROPACK 8 MEE 4108
K841497
Nihon Kohden America, Inc.
Neurology · 58d
Cleared Apr 30, 1984
NEUROTRAC
K841110
Interspec, Inc.
Neurology · 76d
Cleared Feb 05, 1981
EVOKED RESPONSE STIMULATORS
K803226
Bio-Logic Systems Corp.
Neurology · 48d
Cleared Aug 04, 1980
PATHFINDER ELECTRODIAGNOSTIC SYSTEM
K801604
Nicolet Biomedical Instruments
Neurology · 21d
Cleared Apr 19, 1978
AUDIO MONITOR-MODEL 8309
K780538
Life-Tech Instruments, Inc.
Neurology · 16d
Cleared May 06, 1977
FIBERSCOPIC SCOPE RECORDER SYSTEM
K770782
Elmed, Inc.
Neurology · 4d

About Product Code GWK - Regulatory Context