FDA 510(k)

Air Next (NVD-02)

K 號：K231416 · 2024-01-18

決定日期2024-01-18

產品代碼BZG

諮詢委員會AN

決定相當於

器材摘要

Air Next (NVD-02) is the device name listed in this FDA 510(k) record. The listed applicant is Nuvoair AB. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K231416. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Air Next (NVD-02)?

Air Next (NVD-02) is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Nuvoair AB. The 510(k) number is K231416.

When did Air Next (NVD-02) receive FDA 510(k) clearance?

Air Next (NVD-02) received FDA 510(k) clearance on 2024-01-18, under 510(k) number K231416.

Who is the listed applicant for Air Next (NVD-02)?

The FDA 510(k) record lists Nuvoair AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air Next (NVD-02)?

The FDA product code for Air Next (NVD-02) is BZG.

其他以 Nuvoair AB 為申請人之記錄

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。

K183089Air Next

相關器械（代碼：BZG）

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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