ImPACT— 510(k) K181223

Substantially Equivalent

Impact Applications, Inc.

FDA 510(k) clearance K181223 for ImPACT, Substantially Equivalent on 2018-10-20. 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: 2018-05-08
Decision date: 2018-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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