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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, auditory, evoked response
Regulation Description Evoked response auditory stimulator.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWJ
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type 510(k)
Regulation Number 882.1900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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