FDA 510(k)

Air Next

K-Number: K183089 · 2020-01-02

Decision Date2020-01-02

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Nuvoair AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231416Air Next (NVD-02)

Related Devices (Code: BZG)

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair AB K230501Spirobank OxiMir Medical International Research USA K230178EasyOne Sky SpirometerNdd Medizintechnik AG K222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.