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U.S. Department of Health and Human Services

Product Classification

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Device reduced- montage standard electroencephalograph
Regulation Description Electroencephalograph.
Definition 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
Physical State May include standard EEG recording hardware (e.g. headbox, cables, CPU, monitor and basic software (needed to display, store and archive EEG and allow user-only annotation and marking); does NOT include electrodes, more complex software used to analyze EEG or automatically detect events, EEG used for PSG or sleep studies, or EEG with > 16 electrodes or more electrodes.
Technical Method Uses electrodes (less than < 16) placed on the scalp or within the brain, via user-specified and/or sponsor-specified locations, to record and display electrical activity of the brain
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOMC
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons