FDA 510(k)

TRON

K-Number: K221230 · 2022-07-28

Decision Date2022-07-28

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TRON is the device name listed in this FDA 510(k) record. The listed applicant is Xoran Technologies, LLC. It received FDA 510(k) clearance on 2022-07-28 under 510(k) number K221230. 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 TRON?

TRON is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is Xoran Technologies, LLC. The 510(k) number is K221230.

When did TRON receive FDA 510(k) clearance?

TRON received FDA 510(k) clearance on 2022-07-28, under 510(k) number K221230.

Who is the listed applicant for TRON?

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

What is the FDA product code for TRON?

The FDA product code for TRON is OWB.

Other records listing Xoran Technologies, 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.

K210257Xoran Workstation, Model 10050 K201825MiniCAT 2D

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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.