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FDA 510(k)

Evolve Nitric Oxide Delivery System

K-Number: K222930 · 2023-12-06

ApplicantMallinckrodt Manufacturing, LLC
Decision Date2023-12-06
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Evolve Nitric Oxide Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Manufacturing, LLC. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K222930. 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 Evolve Nitric Oxide Delivery System?

Evolve Nitric Oxide Delivery System is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Mallinckrodt Manufacturing, LLC. The 510(k) number is K222930.

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

Evolve Nitric Oxide Delivery System received FDA 510(k) clearance on 2023-12-06, under 510(k) number K222930.

Who is the listed applicant for Evolve Nitric Oxide Delivery System?

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

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

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

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Other records listing Mallinckrodt Manufacturing, LLC 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.

K242578EVOLVE Nitric Oxide Delivery SystemK211153Inomax DSIRK200389INOmax DSIR Plus

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.K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics

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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