FDA 510(k)

Sistema ARTAS

Número K: K173358 · 2018-03-16

Data da decisão2018-03-16

Código do produtoONA

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARTAS System is the device name listed in this FDA 510(k) record. The listed applicant is Restoration Robotics, Inc.. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K173358. The device is classified under product code ONA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARTAS System?

ARTAS System is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Restoration Robotics, Inc.. The 510(k) number is K173358.

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

ARTAS System received FDA 510(k) clearance on 2018-03-16, under 510(k) number K173358.

Who is the listed applicant for ARTAS System?

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

What is the FDA product code for ARTAS System?

The FDA product code for ARTAS System is ONA.

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