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FDA 510(k)

ImPACT

K-Number: K170209 · 2017-02-23

ApplicantImpact Applications, Inc.
Decision Date2017-02-23
Product CodePOM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ImPACT is a medical device manufactured by Impact Applications, Inc.. It received FDA 510(k) clearance on 2017-02-23 under approval number K170209. 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?

ImPACT is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Impact Applications, Inc.. The 510(k) number is K170209.

When was ImPACT approved by the FDA?

ImPACT received FDA 510(k) clearance on 2017-02-23, under approval number K170209.

What company makes ImPACT?

ImPACT is manufactured by Impact Applications, Inc..

What is the FDA product code for ImPACT?

The FDA product code for ImPACT is POM.

Other Devices by Impact Applications, Inc.

DEN150037ImPACT Computerized Neurocognitive Concussion Management Aid K170551ImPACT Quick Test K181223ImPACT K202485ImPACT Version 4 K231688ImPACT Version 4

Related Devices (Code: POM)

DEN150037ImPACT Computerized Neurocognitive Concussion Management AidImpact Applications, Inc. K170551ImPACT Quick TestImpact Applications, Inc. K181223ImPACTImpact Applications, Inc. K202485ImPACT Version 4Impact Applications, Inc. K201376ANAM Test SystemVista Lifesciences, Inc. K231688ImPACT Version 4Impact Applications, Inc.

Official Source

View on FDA Database →

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

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