Cleared Traditional

Air Next

K183089 · Nuvoair AB · Anesthesiology
Jan 2020
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K183089 is an FDA 510(k) clearance for the Air Next, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Nuvoair AB (Stockholm, SE). The FDA issued a Cleared decision on January 2, 2020, 422 days after receiving the submission on November 6, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K183089 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2018
Decision Date January 02, 2020
Days to Decision 422 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