FDA 510(k)

MyLabSix CrystaLine

Número K: K162290 · 2016-10-14

Data da decisão2016-10-14

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

MyLabSix CrystaLine is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K162290. 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 MyLabSix CrystaLine?

MyLabSix CrystaLine is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Esaote, S.p.A.. The 510(k) number is K162290.

When did MyLabSix CrystaLine receive FDA 510(k) clearance?

MyLabSix CrystaLine received FDA 510(k) clearance on 2016-10-14, under 510(k) number K162290.

Who is the listed applicant for MyLabSix CrystaLine?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MyLabSix CrystaLine?

The FDA product code for MyLabSix CrystaLine is IYN.

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Outros registros que listam Esaote, S.p.A. como candidato(a)

K261331I-Genius (100019400)K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

Ver todos os 25 dispositivos →

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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