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 Epitel, Inc., Forest Devices, Inc. and Neurosteer, Inc..
FDA 510(k) Cleared Reduced- Montage Standard Electroencephalograph Devices (Product Code OMC)
About Product Code OMC - Regulatory Context
510(k) Submission Activity
28 total 510(k) submissions under product code OMC since 1978, with 28 receiving FDA clearance (average review time: 143 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for OMC submissions have been consistent, averaging 155 days recently vs 139 days historically.
OMC devices are reviewed by the Neurology panel. Browse all Neurology devices →