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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K231416
Device Name Air Next (NVD-02)
Applicant
NuvoAir AB
17D Riddargatan Stockholm, SE 11457
Stockholm,  SE
Applicant Contact Furat Shawki
Correspondent
NuvoAir AB
17D Riddargatan Stockholm, SE 11457
Stockholm,  SE 11457
Correspondent Contact Daniel Keenan
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/16/2023
Decision Date 01/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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