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FDA 510(k)

The NOxBOXi Nitric Oxide Delivery System

K-Number: K201339 · 2020-06-19

ApplicantPraxair, Inc.
Decision Date2020-06-19
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Related Devices (Code: MRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLCK242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLCK233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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