FDA 510(k)

ZED Link

Número K: K180549 · 2018-04-12

Data da decisão2018-04-12

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ZED Link is the device name listed in this FDA 510(k) record. The listed applicant is Zed Technologies. It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K180549. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ZED Link?

ZED Link is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is Zed Technologies. The 510(k) number is K180549.

When did ZED Link receive FDA 510(k) clearance?

ZED Link received FDA 510(k) clearance on 2018-04-12, under 510(k) number K180549.

Who is the listed applicant for ZED Link?

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

What is the FDA product code for ZED Link?

The FDA product code for ZED Link is LLZ.

Dispositivos Relacionados (Código: LLZ)

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