ImPACT Computerized Neurocognitive Concussion Management Aid— 510(k) DEN150037

Name: FDA 510(k) clearance DEN150037
Creator: U.S. Food and Drug Administration
Published: 2016-08-22

Unknown

Impact Applications, Inc.

FDA 510(k) clearance DEN150037 for ImPACT Computerized Neurocognitive Concussion Management Aid, Unknown on 2016-08-22. Applicant: Impact Applications, Inc.. Device class: 2.

Clearance details

Applicant: Impact Applications, Inc.
Product code: Code POM
Device class: Class 2
Regulation: 21 CFR 882.1471
Advisory panel: Neurology
Date received: 2015-08-11
Decision date: 2016-08-22
Decision: Unknown
Clearance type: Direct
Location: Pittsburgh, PA, US

View on FDA.gov ↗

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