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U.S. Department of Health and Human Services

Product Classification

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Device nystagmograph
Regulation Description Nystagmograph.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWN
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 882.1460
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons