FDA 510(k)

Relign System

Número K: K162770 · 2017-01-04

Data da decisão2017-01-04

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Relign System is the device name listed in this FDA 510(k) record. The listed applicant is Relign Corporation. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K162770. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Relign System?

Relign System is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Relign Corporation. The 510(k) number is K162770.

When did Relign System receive FDA 510(k) clearance?

Relign System received FDA 510(k) clearance on 2017-01-04, under 510(k) number K162770.

Who is the listed applicant for Relign System?

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

What is the FDA product code for Relign System?

The FDA product code for Relign System is GEI.

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Outros registros que listam Relign Corporation como candidato(a)

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Fonte oficial

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