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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 Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1890
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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