FDA 510(k)

Intellitorq

Número K: K180092 · 2018-03-08

Data da decisão2018-03-08

Código do produtoHXC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intellitorq is the device name listed in this FDA 510(k) record. The listed applicant is Gauthier Biomedical, Inc.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K180092. The device is classified under product code HXC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Intellitorq?

Intellitorq is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Gauthier Biomedical, Inc.. The 510(k) number is K180092.

When did Intellitorq receive FDA 510(k) clearance?

Intellitorq received FDA 510(k) clearance on 2018-03-08, under 510(k) number K180092.

Who is the listed applicant for Intellitorq?

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

What is the FDA product code for Intellitorq?

The FDA product code for Intellitorq is HXC.

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