FDA 510(k)

F&P Evora Full Face Mask

K-번호: K212371 · 2022-03-18

결정일2022-03-18

제품 코드BZD

자문 위원회AN

결정Substantially Equivalent

기기 요약

F&P Evora Full Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K212371. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the F&P Evora Full Face Mask?

F&P Evora Full Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K212371.

When did F&P Evora Full Face Mask receive FDA 510(k) clearance?

F&P Evora Full Face Mask received FDA 510(k) clearance on 2022-03-18, under 510(k) number K212371.

Who is the listed applicant for F&P Evora Full Face Mask?

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

What is the FDA product code for F&P Evora Full Face Mask?

The FDA product code for F&P Evora Full Face Mask is BZD.

Fisher & Paykel Healthcare, Ltd.를 신청인으로 등재한 기타 기록

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