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U.S. Department of Health and Human Services

Product Classification

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Device magnetoencephalograph
Regulation Description Electroencephalograph.
Definition Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.
Physical State Magnetoencephalograph recording device (hardware, basic software)
Technical Method Uses a helmet with sensors to record the magnetic activity of the brain
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOLY
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
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
Third Party Review
Accredited Persons