FDA 510(k)

Air Next (NVD-02)

K-Number: K231416 · 2024-01-18

Decision Date2024-01-18

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

K183089Air Next

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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.