FDA 510(k)

The NOxBOXi Nitric Oxide Delivery System

Número K: K201339 · 2020-06-19

Data da decisão2020-06-19

Código do produtoMRN

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

The NOxBOXi Nitric Oxide Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Praxair, Inc.. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K201339. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the The NOxBOXi Nitric Oxide Delivery System?

The NOxBOXi Nitric Oxide Delivery System is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Praxair, Inc.. The 510(k) number is K201339.

When did The NOxBOXi Nitric Oxide Delivery System receive FDA 510(k) clearance?

The NOxBOXi Nitric Oxide Delivery System received FDA 510(k) clearance on 2020-06-19, under 510(k) number K201339.

Who is the listed applicant for The NOxBOXi Nitric Oxide Delivery System?

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

What is the FDA product code for The NOxBOXi Nitric Oxide Delivery System?

The FDA product code for The NOxBOXi Nitric Oxide Delivery System is MRN.

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