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FDA 510(k)

Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J

Número K: K182457 · 2019-04-18

RequerenteBrivant Limited (Lake Region Medical)
Data da decisão2019-04-18
Código do produtoDQX
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J is the device name listed in this FDA 510(k) record. The listed applicant is Brivant Limited (Lake Region Medical). It received FDA 510(k) clearance on 2019-04-18 under 510(k) number K182457. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J?

Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J is a medical device that received FDA 510(k) clearance on 2019-04-18. The listed applicant is Brivant Limited (Lake Region Medical). The 510(k) number is K182457.

When did Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J receive FDA 510(k) clearance?

Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J received FDA 510(k) clearance on 2019-04-18, under 510(k) number K182457.

Who is the listed applicant for Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J?

The FDA 510(k) record lists Brivant Limited (Lake Region Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J?

The FDA product code for Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J is DQX.

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Fonte oficial

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