FDA 510(k)

FLIX-EMS

Número K: K181419 · 2019-05-14

Data da decisão2019-05-14

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

FLIX-EMS is the device name listed in this FDA 510(k) record. The listed applicant is Casgarum Investment, S.L.. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K181419. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FLIX-EMS?

FLIX-EMS is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Casgarum Investment, S.L.. The 510(k) number is K181419.

When did FLIX-EMS receive FDA 510(k) clearance?

FLIX-EMS received FDA 510(k) clearance on 2019-05-14, under 510(k) number K181419.

Who is the listed applicant for FLIX-EMS?

The FDA 510(k) record lists Casgarum Investment, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLIX-EMS?

The FDA product code for FLIX-EMS is NGX.

Dispositivos Relacionados (Código: NGX)

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Fonte oficial

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