FDA 510(k)

TCL3 Motion Tracking System

Número K: K203451 · 2021-04-28

Data da decisão2021-04-28

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Tracinnovations Aps. The 510(k) number is K203451.

When did TCL3 Motion Tracking System receive FDA 510(k) clearance?

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

Who is the listed applicant for TCL3 Motion Tracking System?

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

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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