FDA 510(k)

Airvo 蒸發器適配器

K 號：K211560 · 2021-12-10

決定日期2021-12-10

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Airvo Nebulizer Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K211560. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Airvo Nebulizer Adapter?

Airvo Nebulizer Adapter is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K211560.

When did Airvo Nebulizer Adapter receive FDA 510(k) clearance?

Airvo Nebulizer Adapter received FDA 510(k) clearance on 2021-12-10, under 510(k) number K211560.

Who is the listed applicant for Airvo Nebulizer Adapter?

The FDA 510(k) record lists Fisher & Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Airvo Nebulizer Adapter?

The FDA product code for Airvo Nebulizer Adapter is CAF.

其他以 Fisher & Paykel Healthcare Limited 為申請人之記錄

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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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