Air Next (NVD-02)
K号: K231416 · 2024-01-18
广告
申请人Nuvoair AB
决定日期2024-01-18
产品代码BZG
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
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.
常见问题
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.
列明Nuvoair AB为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：BZG）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 肺功能仪 (TD-7301)Gostar Co., Ltd.K230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky 肺功能仪Ndd Medizintechnik AGK222525Alveoair 数字肺功能仪Roundworks Technologies Private LimitedK222443空气压缩腿部按摩器（MM0520，MM0521，MM0522）Feellife Health, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告