GWS · Class I · 21 CFR 882.1420

FDA Product Code GWS: Analyzer, Spectrum, Electroencephalogram Signal

Leading manufacturers include Teca, Inc., Nihon Kohden America, Inc. and Persyst Development Corp..

15
Total
15
Cleared
122d
Avg days
1980
Since

FDA 510(k) Cleared Analyzer, Spectrum, Electroencephalogram Signal Devices (Product Code GWS)

15 devices
1–15 of 15
Cleared Mar 09, 1998
PERSYST PRISM
K974718
Persyst Development Corp.
Neurology · 82d
Cleared Aug 20, 1986
OEE_7102 EEG/TREND MONITOR
K854662
Nihon Kohden America, Inc.
Neurology · 273d
Cleared May 20, 1985
NEUROLAB II
K844481
Teca, Inc.
Neurology · 182d

About Product Code GWS - Regulatory Context