FDA 510(k)

RUS

Número K: K233457 · 2024-07-12

Data da decisão2024-07-12

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

RUS is the device name listed in this FDA 510(k) record. The listed applicant is Hutom, Inc.. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K233457. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RUS?

RUS is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Hutom, Inc.. The 510(k) number is K233457.

When did RUS receive FDA 510(k) clearance?

RUS received FDA 510(k) clearance on 2024-07-12, under 510(k) number K233457.

Who is the listed applicant for RUS?

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

What is the FDA product code for RUS?

The FDA product code for RUS is QIH.

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