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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 a medical device manufactured by Mallinckrodt Manufacturing, LLC. It received FDA 510(k) clearance on 2023-12-06 under approval 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. It is manufactured by Mallinckrodt Manufacturing, LLC. The 510(k) number is K222930.

When was Evolve Nitric Oxide Delivery System approved by the FDA?

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

What company makes Evolve Nitric Oxide Delivery System?

Evolve Nitric Oxide Delivery System is manufactured by Mallinckrodt Manufacturing, LLC.

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 Devices by Mallinckrodt Manufacturing, LLC

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Related Devices (Code: MRN)

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Official Source

View on FDA Database →

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

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