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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, photic, evoked response
Regulation Description Evoked response photic stimulator.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWE
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type 510(k)
Regulation Number 882.1890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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