GWK · Class II · 21 CFR 882.1845

FDA Product Code GWK: Conditioner, Signal, Physiological

Leading manufacturers include Respironics, Inc. and Nihon Kohden America, Inc..

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 Jun 28, 1991
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
K905594
Nihon Kohden America, Inc.
Neurology · 197d
Cleared Jun 07, 1984
NEUROPACK 8 MEE 4108
K841497
Nihon Kohden America, Inc.
Neurology · 58d

About Product Code GWK - Regulatory Context