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FDA 510(k)

EVOLVE Nitric Oxide Delivery System

K-Number: K240410 · 2024-05-28

ApplicantMalinckrodt Manufacturing, LLC
Decision Date2024-05-28
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EVOLVE Nitric Oxide Delivery System is a medical device manufactured by Malinckrodt Manufacturing, LLC. It received FDA 510(k) clearance on 2024-05-28 under approval number K240410. 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 2024-05-28. It is manufactured by Malinckrodt Manufacturing, LLC. The 510(k) number is K240410.

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

EVOLVE Nitric Oxide Delivery System received FDA 510(k) clearance on 2024-05-28, under approval number K240410.

What company makes EVOLVE Nitric Oxide Delivery System?

EVOLVE Nitric Oxide Delivery System is manufactured by Malinckrodt 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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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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