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FDA 510(k)

EZTrack

K-Number: K201910 · 2020-12-22

Decision Date2020-12-22
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EZTrack is the device name listed in this FDA 510(k) record. The listed applicant is Neurologic, LLC. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K201910. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZTrack?

EZTrack is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Neurologic, LLC. The 510(k) number is K201910.

When did EZTrack receive FDA 510(k) clearance?

EZTrack received FDA 510(k) clearance on 2020-12-22, under 510(k) number K201910.

Who is the listed applicant for EZTrack?

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

What is the FDA product code for EZTrack?

The FDA product code for EZTrack is OLX.

Related Devices (Code: OLX)

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.

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.