FDA 510(k)

ImPACT Version 4

K-Number: K202485 · 2020-12-25

Decision Date2020-12-25

Product CodePOM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ImPACT Version 4 is the device name listed in this FDA 510(k) record. The listed applicant is Impact Applications, Inc.. It received FDA 510(k) clearance on 2020-12-25 under 510(k) number K202485. 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 2020-12-25. The listed applicant is Impact Applications, Inc.. The 510(k) number is K202485.

When did ImPACT Version 4 receive FDA 510(k) clearance?

ImPACT Version 4 received FDA 510(k) clearance on 2020-12-25, under 510(k) number K202485.

Who is the listed applicant for ImPACT Version 4?

The FDA 510(k) record lists Impact Applications, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImPACT Version 4?

The FDA product code for ImPACT Version 4 is POM.

Other records listing Impact Applications, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231688ImPACT Version 4 K181223ImPACT K170551ImPACT Quick Test K170209ImPACT

Related Devices (Code: POM)

K241737Sway System Sports PlusSway Medical, Inc.K231688ImPACT Version 4Impact Applications, Inc.K201376ANAM Test SystemVista Lifesciences, Inc.K181223ImPACTImpact Applications, Inc.K170551ImPACT Quick TestImpact Applications, Inc.K170209ImPACTImpact 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.