FDA 510(k)

ImPACT Quick Test

K-Number: K170551 · 2017-06-21

Decision Date2017-06-21

Product CodePOM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ImPACT Quick Test is a medical device manufactured by Impact Applications, Inc.. It received FDA 510(k) clearance on 2017-06-21 under approval number K170551. The device is classified under product code POM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImPACT Quick Test?

ImPACT Quick Test is a medical device that received FDA 510(k) clearance on 2017-06-21. It is manufactured by Impact Applications, Inc.. The 510(k) number is K170551.

When was ImPACT Quick Test approved by the FDA?

ImPACT Quick Test received FDA 510(k) clearance on 2017-06-21, under approval number K170551.

What company makes ImPACT Quick Test?

ImPACT Quick Test is manufactured by Impact Applications, Inc..

What is the FDA product code for ImPACT Quick Test?

The FDA product code for ImPACT Quick Test is POM.

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Related Devices (Code: POM)

DEN150037ImPACT Computerized Neurocognitive Concussion Management AidImpact Applications, Inc. K170209ImPACTImpact Applications, Inc. K181223ImPACTImpact Applications, Inc. K202485ImPACT Version 4Impact Applications, Inc. K201376ANAM Test SystemVista Lifesciences, Inc. K231688ImPACT Version 4Impact Applications, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.