FDA 510(k)

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K-번호: K222930 · 2023-12-06

결정일2023-12-06

제품 코드MRN

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기기 요약

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.

자주 묻는 질문

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.

Mallinckrodt Manufacturing, LLC를 신청인으로 등재한 기타 기록

K242578에볼브 일산화질소 전달 시스템 K211153인모کس DSIR K200389INOmax DSIR 플러스

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