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FDA 510(k)

TrackX

K-Number: K200360 · 2020-03-05

ApplicantTrack X Technology, LLC
Decision Date2020-03-05
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TrackX is a medical device manufactured by Track X Technology, LLC. It received FDA 510(k) clearance on 2020-03-05 under approval 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. It is manufactured by Track X Technology, LLC. The 510(k) number is K200360.

When was TrackX approved by the FDA?

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

What company makes TrackX?

TrackX is manufactured by Track X Technology, LLC.

What is the FDA product code for TrackX?

The FDA product code for TrackX is OWB.

Other Devices by Track X Technology, LLC

K173736TrackX

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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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