FDA 510(k)

Optiflow 氧氣套件

K 號：K211096 · 2022-01-28

決定日期2022-01-28

產品代碼BTT

諮詢委員會AN

決定相當於

器材摘要

Optiflow Oxygen Kit 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 2022-01-28 under 510(k) number K211096. 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 Optiflow Oxygen Kit?

Optiflow Oxygen Kit is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K211096.

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

Optiflow Oxygen Kit received FDA 510(k) clearance on 2022-01-28, under 510(k) number K211096.

Who is the listed applicant for Optiflow Oxygen Kit?

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 Optiflow Oxygen Kit?

The FDA product code for Optiflow Oxygen Kit 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。

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官方來源

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