ImPACT Version 4— 510(k) K231688

Substantially Equivalent

Impact Applications, Inc.

FDA 510(k) clearance K231688 for ImPACT Version 4, Substantially Equivalent on 2023-09-16. 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: 2023-06-09
Decision date: 2023-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coralville, IA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Impact Applications, Inc.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.