FDA 510(k)

F&P Optiflow 鼻氧氣管路附二氧化碳採樣功能

K 號：K201723 · 2021-03-16

決定日期2021-03-16

產品代碼BTT

諮詢委員會AN

決定相當於

器材摘要

F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling 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 2021-03-16 under 510(k) number K201723. 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 Nasal Oxygen Cannula with CO2 Sampling?

F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling is a medical device that received FDA 510(k) clearance on 2021-03-16. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K201723.

When did F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling receive FDA 510(k) clearance?

F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling received FDA 510(k) clearance on 2021-03-16, under 510(k) number K201723.

Who is the listed applicant for F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling?

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 Nasal Oxygen Cannula with CO2 Sampling?

The FDA product code for F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling is BTT.

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）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262268Optiflow 氧氣套件 (AA484J)Fisher and Paykel Healthcare Limited K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U 呼吸濕化器Flexicare Medical Limited.K251419生物加倫尼克實驗室靜脈注射用无菌水，USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ 過濾鼻接口配二氧化碳採樣功能 (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® 舒適流鼻管預產期、嬰兒；Hudson RCI® 舒適流 Plus 及軟 Plus 鼻管超小號Medline Industries, LP

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