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FDA 510(k)

VIANOX DELIVERY SYSTEM, MODEL II

K-Number: K033779 · 2004-01-26

ApplicantPulmonox Medical, Inc.
Decision Date2004-01-26
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VIANOX DELIVERY SYSTEM, MODEL II is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonox Medical, Inc.. It received FDA 510(k) clearance on 2004-01-26 under 510(k) number K033779. 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 VIANOX DELIVERY SYSTEM, MODEL II?

VIANOX DELIVERY SYSTEM, MODEL II is a medical device that received FDA 510(k) clearance on 2004-01-26. The listed applicant is Pulmonox Medical, Inc.. The 510(k) number is K033779.

When did VIANOX DELIVERY SYSTEM, MODEL II receive FDA 510(k) clearance?

VIANOX DELIVERY SYSTEM, MODEL II received FDA 510(k) clearance on 2004-01-26, under 510(k) number K033779.

Who is the listed applicant for VIANOX DELIVERY SYSTEM, MODEL II?

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

What is the FDA product code for VIANOX DELIVERY SYSTEM, MODEL II?

The FDA product code for VIANOX DELIVERY SYSTEM, MODEL II is MRN.

Related Clinical Trials

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.

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Other records listing Pulmonox Medical, Inc. as applicant

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.

K023014VIANOX DELIVERY SYSTEM, MODEL I

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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