Air Next (NVD-02)

FDA 510(k) K231416 · Nuvoair AB

Substantially Equivalent

510(k) numberK231416

Submission

Device name
Air Next (NVD-02)
Applicant
Nuvoair AB
Stockholm, SE
Received
May 16, 2023
Decision date
January 18, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZG – Spirometer, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

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Questions and answers

When was Air Next (NVD-02) cleared by the FDA?

Air Next (NVD-02) (K231416) received a 510(k) decision of Substantially Equivalent on January 18, 2024, 247 days after the submission was received.

What is the product code of K231416?

The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.