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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 Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostics (DHT5A)
Submission Type 510(k)
Regulation Number 882.1900
Device Class 2
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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