Freestyle Flex — 510(k) de la FDA K191653

Resumen del dispositivo

Freestyle Flex is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K191653. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Freestyle Flex?

Freestyle Flex is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Medela AG. The 510(k) number is K191653.

When did Freestyle Flex receive FDA 510(k) clearance?

Freestyle Flex received FDA 510(k) clearance on 2019-10-17, under 510(k) number K191653.

Who is the listed applicant for Freestyle Flex?

The FDA 510(k) record lists Medela AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freestyle Flex?

The FDA product code for Freestyle Flex is HGX.

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Fuente oficial

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