FDA 510(k)

Air Next

K 號：K183089 · 2020-01-02

決定日期2020-01-02

產品代碼BZG

諮詢委員會AN

決定相當於

器材摘要

Air Next is the device name listed in this FDA 510(k) record. The listed applicant is Nuvoair AB. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K183089. 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?

Air Next is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Nuvoair AB. The 510(k) number is K183089.

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

Air Next received FDA 510(k) clearance on 2020-01-02, under 510(k) number K183089.

Who is the listed applicant for Air Next?

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?

The FDA product code for Air Next 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。

K231416Air Next (NVD-02)

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。

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 肺功能儀 (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair AB K230501斯匹羅班克氧氣Mir Medical International Research USA K230178EasyOne 天空肺功能儀Ndd Medizintechnik AG K222525Alveoair數位肺功能儀Roundworks Technologies Private Limited

官方來源

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