Cleared Traditional

Air Next (NVD-02)

K231416 · Nuvoair AB · Anesthesiology
Jan 2024
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K231416 is an FDA 510(k) clearance for the Air Next (NVD-02), a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Nuvoair AB (Stockholm, SE). The FDA issued a Cleared decision on January 18, 2024, 247 days after receiving the submission on May 16, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K231416 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2023
Decision Date January 18, 2024
Days to Decision 247 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840