OMC · Class II · 21 CFR 882.1400

FDA Product Code OMC: Reduced- Montage Standard Electroencephalograph

Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes

Leading manufacturers include Cleveland Medical Devices, Inc., Advanced Brain Monitoring, Inc. and Epitel, Inc..

28
Total
28
Cleared
143d
Avg days
1978
Since
28 devices
25–28 of 28
Cleared Feb 19, 2002
CRYSTAL MONITOR MODEL 16
K013863
Cleveland Medical Devices, Inc.
Neurology · 90d
Cleared Jul 05, 2000
CRYSTAL-EEG MODEL 15
K001110
Cleveland Medical Devices, Inc.
Neurology · 90d
Cleared May 22, 1997
CRYSTAL-EEG MODEL 10 (MODEL 10)
K970672
Cleveland Medical Devices, Inc.
Neurology · 87d
Cleared Aug 23, 1978
ACCESSORY TO ECG ANALYSIS SYS.
K781130
Oxford Medilog, Inc.
Neurology · 49d