FDA 510(k)

Optiflow Oxygen Kit (AA484J)

K-번호: K262268 · 2026-08-27

결정일2026-08-27

제품 코드BTT

자문 위원회AN

결정Substantially Equivalent

기기 요약

Optiflow Oxygen Kit (AA484J) is the device name listed in this FDA 510(k) record. The listed applicant is Fisher and Paykel Healthcare Limited. It received FDA 510(k) clearance on 2026-08-27 under 510(k) number K262268. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Optiflow Oxygen Kit (AA484J)?

Optiflow Oxygen Kit (AA484J) is a medical device that received FDA 510(k) clearance on 2026-08-27. The listed applicant is Fisher and Paykel Healthcare Limited. The 510(k) number is K262268.

When did Optiflow Oxygen Kit (AA484J) receive FDA 510(k) clearance?

Optiflow Oxygen Kit (AA484J) received FDA 510(k) clearance on 2026-08-27, under 510(k) number K262268.

Who is the listed applicant for Optiflow Oxygen Kit (AA484J)?

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

What is the FDA product code for Optiflow Oxygen Kit (AA484J)?

The FDA product code for Optiflow Oxygen Kit (AA484J) is BTT.

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