FDA 510(k)

AeroNOx 2.0 질소산화물 티터레이션 및 모니터링 시스템

K-번호: K193481 · 2020-03-10

결정일2020-03-10

제품 코드MRN

자문 위원회AN

결정Substantially Equivalent

기기 요약

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2020-03-10 under 510(k) number K193481. 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 AeroNOx 2.0 Nitric Oxide Titration & Monitoring System?

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System is a medical device that received FDA 510(k) clearance on 2020-03-10. The listed applicant is International Biomedical. The 510(k) number is K193481.

When did AeroNOx 2.0 Nitric Oxide Titration & Monitoring System receive FDA 510(k) clearance?

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System received FDA 510(k) clearance on 2020-03-10, under 510(k) number K193481.

Who is the listed applicant for AeroNOx 2.0 Nitric Oxide Titration & Monitoring System?

The FDA 510(k) record lists International Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AeroNOx 2.0 Nitric Oxide Titration & Monitoring System?

The FDA product code for AeroNOx 2.0 Nitric Oxide Titration & Monitoring System is MRN.

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