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FDA 510(k)

TCL3 Motion Tracking System

K-Number: K203451 · 2021-04-28

ApplicantTracinnovations Aps
Decision Date2021-04-28
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TCL3 Motion Tracking System is a medical device manufactured by Tracinnovations Aps. It received FDA 510(k) clearance on 2021-04-28 under approval number K203451. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCL3 Motion Tracking System?

TCL3 Motion Tracking System is a medical device that received FDA 510(k) clearance on 2021-04-28. It is manufactured by Tracinnovations Aps. The 510(k) number is K203451.

When was TCL3 Motion Tracking System approved by the FDA?

TCL3 Motion Tracking System received FDA 510(k) clearance on 2021-04-28, under approval number K203451.

What company makes TCL3 Motion Tracking System?

TCL3 Motion Tracking System is manufactured by Tracinnovations Aps.

What is the FDA product code for TCL3 Motion Tracking System?

The FDA product code for TCL3 Motion Tracking System is LNH.

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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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