FDA 510(k)

Liba3 System

Número K: K182532 · 2019-05-15

Data da decisão2019-05-15

Código do produtoDSI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Liba3 System is the device name listed in this FDA 510(k) record. The listed applicant is National Cardiac, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K182532. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Liba3 System?

Liba3 System is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is National Cardiac, Inc.. The 510(k) number is K182532.

When did Liba3 System receive FDA 510(k) clearance?

Liba3 System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K182532.

Who is the listed applicant for Liba3 System?

The FDA 510(k) record lists National Cardiac, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liba3 System?

The FDA product code for Liba3 System is DSI.

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