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U.S. Department of Health and Human Services

Product Classification

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Device computerized cognitive assessment aid for concussion
Regulation Description Computerized cognitive assessment aid for concussion.
Definition For use as an assessment aid in the management of concussion.
Physical State The device consists of a software program that administers a neurocognitive test battery to a subject in order to assess their cognitive status. The device may use off-the-shelf computers or a novel device.
Technical Method Uses a software-based cognitive test battery as an assessment aid in the management of concussion.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePOM
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NDNB)
Submission Type 510(k)
Regulation Number 882.1471
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible