FDA 510(k)

Vial Adapter Ø13mm

Número K: K220856 · 2022-06-21

RequerenteAvenir Performance Européenne Medical (Apem)

Data da decisão2022-06-21

Código do produtoLHI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vial Adapter Ø13mm is the device name listed in this FDA 510(k) record. The listed applicant is Avenir Performance Européenne Medical (Apem). It received FDA 510(k) clearance on 2022-06-21 under 510(k) number K220856. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vial Adapter Ø13mm?

Vial Adapter Ø13mm is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is Avenir Performance Européenne Medical (Apem). The 510(k) number is K220856.

When did Vial Adapter Ø13mm receive FDA 510(k) clearance?

Vial Adapter Ø13mm received FDA 510(k) clearance on 2022-06-21, under 510(k) number K220856.

Who is the listed applicant for Vial Adapter Ø13mm?

The FDA 510(k) record lists Avenir Performance Européenne Medical (Apem) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial Adapter Ø13mm?

The FDA product code for Vial Adapter Ø13mm is LHI.

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Fonte oficial

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