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FDA 510(k)

F&P Optiflow 遮菌鼻接口與麻醉口罩相容性 (AA041J)

K 號:K234058 · 2024-08-08

決定日期2024-08-08
產品代碼BTT
諮詢委員會AN
決定相當於

器材摘要

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.

常見問題

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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其他以 Fisher & Paykel Healthcare, Ltd. 為申請人之記錄

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相關器械(代碼:BTT)

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官方來源

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