FDA 510(k)

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System

Número K: K152361 · 2016-01-14

Data da decisão2016-01-14

Código do produtoIZQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is the device name listed in this FDA 510(k) record. The listed applicant is Liebel-Flarsheim Company, LLC. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K152361. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Liebel-Flarsheim Company, LLC. The 510(k) number is K152361.

When did OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System receive FDA 510(k) clearance?

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152361.

Who is the listed applicant for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

The FDA 510(k) record lists Liebel-Flarsheim Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

The FDA product code for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is IZQ.

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