Air Next
K-Number: K183089 · 2020-01-02
ApplicantNuvoair AB
Decision Date2020-01-02
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Air Next is a medical device manufactured by Nuvoair AB. It received FDA 510(k) clearance on 2020-01-02 under approval 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. It is manufactured by Nuvoair AB. The 510(k) number is K183089.
When was Air Next approved by the FDA?
Air Next received FDA 510(k) clearance on 2020-01-02, under approval number K183089.
What company makes Air Next?
Air Next is manufactured by Nuvoair AB.
What is the FDA product code for Air Next?
The FDA product code for Air Next is BZG.
Other Devices by Nuvoair AB
Related Devices (Code: BZG)
K161676Q13 SPIROLYSER®Fim Medical
K160116SpiroScoutGanshorn Medizin Electronic GmbH
K160253Vitalograph Model 6300 microVitalograph (Ireland) , Ltd.
K150515IQSense Flow Sensor MouthpieceSdi Diagnostics, Inc.
K163249GoSpiroMonitored Therapeutics, Inc.
K161536EasyOne Air SpirometerNdd Medizintechnik AG
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.