FDA 510(k)

F&P Visairo NIV 面罩系列

K 號：K203449 · 2021-04-14

決定日期2021-04-14

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

F&P Visairo NIV Mask Range 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 2021-04-14 under 510(k) number K203449. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the F&P Visairo NIV Mask Range?

F&P Visairo NIV Mask Range is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K203449.

When did F&P Visairo NIV Mask Range receive FDA 510(k) clearance?

F&P Visairo NIV Mask Range received FDA 510(k) clearance on 2021-04-14, under 510(k) number K203449.

Who is the listed applicant for F&P Visairo NIV Mask Range?

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 Visairo NIV Mask Range?

The FDA product code for F&P Visairo NIV Mask Range is CBK.

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

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相關器械（代碼：CBK）

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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