FDA 510(k)

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

K-번호: K191624 · 2020-03-09

결정일2020-03-09

제품 코드MNT

자문 위원회AN

결정Substantially Equivalent

기기 요약

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2020-03-09 under 510(k) number K191624. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K191624.

When did F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version receive FDA 510(k) clearance?

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version received FDA 510(k) clearance on 2020-03-09, under 510(k) number K191624.

Who is the listed applicant for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

The FDA 510(k) record lists Fisher & Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

The FDA product code for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is MNT.

Fisher & Paykel Healthcare Limited를 신청인으로 등재한 기타 기록

9개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.