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FDA 510(k)

ImPACT Version 4

K-Number: K231688 · 2023-09-16

ApplicantImpact Applications, Inc.
Decision Date2023-09-16
Product CodePOM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ImPACT Version 4 is a medical device manufactured by Impact Applications, Inc.. It received FDA 510(k) clearance on 2023-09-16 under approval number K231688. 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 Version 4?

ImPACT Version 4 is a medical device that received FDA 510(k) clearance on 2023-09-16. It is manufactured by Impact Applications, Inc.. The 510(k) number is K231688.

When was ImPACT Version 4 approved by the FDA?

ImPACT Version 4 received FDA 510(k) clearance on 2023-09-16, under approval number K231688.

What company makes ImPACT Version 4?

ImPACT Version 4 is manufactured by Impact Applications, Inc..

What is the FDA product code for ImPACT Version 4?

The FDA product code for ImPACT Version 4 is POM.

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Other Devices by Impact Applications, Inc.

DEN150037ImPACT Computerized Neurocognitive Concussion Management Aid K170551ImPACT Quick Test K170209ImPACT K181223ImPACT K202485ImPACT Version 4

Related Devices (Code: POM)

DEN150037ImPACT Computerized Neurocognitive Concussion Management AidImpact Applications, Inc. K170551ImPACT Quick TestImpact Applications, Inc. K170209ImPACTImpact Applications, Inc. K181223ImPACTImpact Applications, Inc. K202485ImPACT Version 4Impact Applications, Inc. K201376ANAM Test SystemVista Lifesciences, 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.

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