FDA 510(k)

Versana Premier

Número K: K200138 · 2020-07-01

RequerenteGe Medical Systems Ultrasound And

Data da decisão2020-07-01

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Versana Premier is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound And. It received FDA 510(k) clearance on 2020-07-01 under 510(k) number K200138. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Versana Premier?

Versana Premier is a medical device that received FDA 510(k) clearance on 2020-07-01. The listed applicant is Ge Medical Systems Ultrasound And. The 510(k) number is K200138.

When did Versana Premier receive FDA 510(k) clearance?

Versana Premier received FDA 510(k) clearance on 2020-07-01, under 510(k) number K200138.

Who is the listed applicant for Versana Premier?

The FDA 510(k) record lists Ge Medical Systems Ultrasound And as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Versana Premier?

The FDA product code for Versana Premier is IYN.

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Outros registros que listam Ge Medical Systems Ultrasound And como candidato(a)

K220882Vivid E80, Vivid E90, Vivid E95 K200708Vivid iq K200743Vivid E80/ Vivid E90/ Vivid E95 K192917ViewPoint 6

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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