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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, spectrum, electroencephalogram signal
Regulation Description Electroencephalogram (EEG) signal spectrum analyzer.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWS
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1420
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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