FDA 510(k)

ImPACT

K-Number: K181223 · 2018-10-20

Decision Date2018-10-20

Product CodePOM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ImPACT 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 2018-10-20 under 510(k) number K181223. 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 2018-10-20. The listed applicant is Impact Applications, Inc.. The 510(k) number is K181223.

When did ImPACT receive FDA 510(k) clearance?

ImPACT received FDA 510(k) clearance on 2018-10-20, under 510(k) number K181223.

Who is the listed applicant for ImPACT?

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?

The FDA product code for ImPACT 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 K202485ImPACT Version 4 K170551ImPACT Quick Test K170209ImPACT

Related Devices (Code: POM)

K241737Sway System Sports PlusSway Medical, Inc.K231688ImPACT Version 4Impact Applications, Inc.K201376ANAM Test SystemVista Lifesciences, Inc.K202485ImPACT Version 4Impact 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.