FDA 510(k)

Rapid HB, Rapid LB, Rapid MB

Número K: K173318 · 2017-10-31

Data da decisão2017-10-31

Código do produtoELW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rapid HB, Rapid LB, Rapid MB is the device name listed in this FDA 510(k) record. The listed applicant is 3M Deutschland GmbH. It received FDA 510(k) clearance on 2017-10-31 under 510(k) number K173318. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Rapid HB, Rapid LB, Rapid MB?

Rapid HB, Rapid LB, Rapid MB is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is 3M Deutschland GmbH. The 510(k) number is K173318.

When did Rapid HB, Rapid LB, Rapid MB receive FDA 510(k) clearance?

Rapid HB, Rapid LB, Rapid MB received FDA 510(k) clearance on 2017-10-31, under 510(k) number K173318.

Who is the listed applicant for Rapid HB, Rapid LB, Rapid MB?

The FDA 510(k) record lists 3M Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid HB, Rapid LB, Rapid MB?

The FDA product code for Rapid HB, Rapid LB, Rapid MB is ELW.

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Fonte oficial

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