FDA 510(k)

Follicle Aspiration Set

Número K: K161970 · 2017-06-14

Data da decisão2017-06-14

Código do produtoMQE

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Follicle Aspiration Set is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2017-06-14 under 510(k) number K161970. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Follicle Aspiration Set?

Follicle Aspiration Set is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K161970.

When did Follicle Aspiration Set receive FDA 510(k) clearance?

Follicle Aspiration Set received FDA 510(k) clearance on 2017-06-14, under 510(k) number K161970.

Who is the listed applicant for Follicle Aspiration Set?

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

What is the FDA product code for Follicle Aspiration Set?

The FDA product code for Follicle Aspiration Set is MQE.

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