FDA 510(k)

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)

K-번호: K234058 · 2024-08-08

결정일2024-08-08

제품 코드BTT

자문 위원회AN

결정Substantially Equivalent

기기 요약

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) 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 2024-08-08 under 510(k) number K234058. 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 F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)?

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K234058.

When did F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) receive FDA 510(k) clearance?

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) received FDA 510(k) clearance on 2024-08-08, under 510(k) number K234058.

Who is the listed applicant for F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)?

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 Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)?

The FDA product code for F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) is BTT.

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