FDA 510(k)

F&P Optiflow Flow Diverter

K-번호: K234053 · 2024-08-09

결정일2024-08-09

제품 코드CBP

자문 위원회AN

결정Substantially Equivalent

기기 요약

F&P Optiflow Flow Diverter 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 2024-08-09 under 510(k) number K234053. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the F&P Optiflow Flow Diverter?

F&P Optiflow Flow Diverter is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K234053.

When did F&P Optiflow Flow Diverter receive FDA 510(k) clearance?

F&P Optiflow Flow Diverter received FDA 510(k) clearance on 2024-08-09, under 510(k) number K234053.

Who is the listed applicant for F&P Optiflow Flow Diverter?

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 Optiflow Flow Diverter?

The FDA product code for F&P Optiflow Flow Diverter is CBP.

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