meddevicedb.com FDA Device Reference

ImPACT Computerized Neurocognitive Concussion Management Aid

DEN150037 Class II Direct
Decision Date
2016-08-22
Sponsor / Applicant
Impact Applications, Inc.

Technical Specification

510(k) Submission ID DEN150037
Product Code POM
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1471
Decision Date 2016-08-22
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ImPACT Computerized Neurocognitive Concussion Management Aid received FDA 510(k) clearance under submission number DEN150037, sponsored by Impact Applications, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-08-22.

Classification & Regulation

This clearance is catalogued under FDA product code POM and 21 CFR 882.1471, within the Neurology review panel as a Class II device.