FDA 510(k)

TrackX

K-Number: K200360 · 2020-03-05

Decision Date2020-03-05

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TrackX is the device name listed in this FDA 510(k) record. The listed applicant is Track X Technology, LLC. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K200360. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrackX?

TrackX is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Track X Technology, LLC. The 510(k) number is K200360.

When did TrackX receive FDA 510(k) clearance?

TrackX received FDA 510(k) clearance on 2020-03-05, under 510(k) number K200360.

Who is the listed applicant for TrackX?

The FDA 510(k) record lists Track X Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrackX?

The FDA product code for TrackX is OWB.

Other records listing Track X Technology, LLC 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.

K173736TrackX

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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.