FDA 510(k)

Inessa System

Número K: K230545 · 2023-12-20

Data da decisão2023-12-20

Código do produtoQFG

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Inessa System is the device name listed in this FDA 510(k) record. The listed applicant is Triple Jump Israel , Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K230545. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Inessa System?

Inessa System is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Triple Jump Israel , Ltd.. The 510(k) number is K230545.

When did Inessa System receive FDA 510(k) clearance?

Inessa System received FDA 510(k) clearance on 2023-12-20, under 510(k) number K230545.

Who is the listed applicant for Inessa System?

The FDA 510(k) record lists Triple Jump Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inessa System?

The FDA product code for Inessa System is QFG.

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